Colonoscopy is a medical procedure used to visualize the interior of the colon and rectum, often studied to improve the effectiveness, safety, and patient experience of the examination. Clinical trials involving colonoscopy explore innovations in pre...
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Found 38 Actively Recruiting clinical trials
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Researchers are evaluating a new oral synbiotic formula called SMT04 to see if it can reduce the recurrence of advanced adenomas and related bacterial gene markers in people who have had colorectal advanced neoplasia removed. The study is a multicenter, double-blinded randomized controlled trial focused on colorectal cancer and its precancerous lesions, exploring how gut microbiome changes may influence disease progression and recurrence. The trial seeks to understand if SMT04 can sustain long-term benefits in lowering harmful bacterial markers linked to colorectal neoplasia. Participants will be randomly assigned to receive either the SMT04 synbiotic formula, which combines probiotics and heat-resistant prebiotics, or an active placebo containing a small amount of vitamin C and inert starch filler with matching appearance and flavor. The trial includes a control group receiving the placebo to compare effects. The SMT04 formula has previously been shown to increase beneficial Bifidobacterium species and reduce certain bacterial gene markers over weeks 2 to 12, but its long-term impact is still being studied. During the year-long study, participants will undergo monitoring to detect any recurrence of advanced colorectal neoplasia through colonoscopies and bacterial gene marker measurements. Researchers will track the incidence and number of recurrent adenomas and advanced neoplasia, as well as changes in bacterial gene markers and their correlation with disease recurrence. The primary outcome is the incidence of recurrent advanced colorectal neoplasia at one year. The study involves regular assessments, including colonoscopy quality checks and histopathological confirmation, to ensure thorough evaluation of treatment effects.
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Researchers are evaluating the effects of adding clonidine to propofol sedation in patients undergoing colonoscopy. The study aims to compare the safety, patient satisfaction, and efficiency of propofol alone versus propofol combined with clonidine. Colonoscopy is a common procedure used for prevention, diagnosis, and treatment of lower digestive tract conditions, and sedation improves patient comfort and procedure quality. The trial explores how clonidine, which acts on alpha2 adrenoceptors to produce sedation and analgesia, may affect sedation outcomes alongside propofol. Participants will be randomly assigned to one of two groups. One group receives propofol sedation maintained by continuous infusion via syringe pump, starting at 25-75 micrograms per kilogram per minute intravenously for 10 to 15 minutes, then adjusted based on clinical response. The other group receives an intravenous dose of clonidine (2 micrograms per kilogram) 30 minutes before starting propofol sedation, administered over 10 minutes. Sedation onset and dosing are carefully regulated to avoid unnecessary sedative exposure. During the study, patients will be monitored for heart rate and blood pressure throughout the colonoscopy procedure. Patient satisfaction and side effects will be assessed 24 hours after surgery. Researchers will track vital signs until the procedure ends and evaluate overall safety and comfort. The study runs from July to September 2024 and includes adults aged 18 to 65 undergoing colonoscopy with specific health criteria.
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Healthy Volunteer
Researchers are studying the quality of bowel preparation in patients with Inflammatory Bowel Disease (IBD) who are undergoing colonoscopy. This project aims to assess how well current bowel preparation protocols are followed across hospitals in China after new 2023 guidelines were introduced. It also seeks to identify risk factors linked to poor bowel preparation and develop a model to predict failed preparation, helping to personalize future bowel prep plans. Participants will follow standard bowel preparation protocols including a low-residue diet and use of bowel cleansing agents like Polyethylene Glycol, following each hospital's routine practice. The study is observational and involves patients aged 18 to 75 years diagnosed with IBD and scheduled for colonoscopy. After colonoscopy, patients complete a questionnaire about factors affecting their bowel preparation quality and details of their prep routine. During the study, researchers will record bowel preparation quality using the Boston Bowel Preparation Scale and collect colonoscopy results and disease activity scores. They will also measure the rate of adequate bowel preparation immediately after the procedure and assess patient satisfaction. Participants are involved in answering questionnaires and undergoing routine colonoscopy as part of their clinical care. The study follows participants from preparation through colonoscopy, with a focus on improving bowel prep standards and outcomes.
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Researchers are investigating the pain-relief mechanism of Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture (TENS-WAA) during unsedated colonoscopy. This single-center, randomized controlled trial uses EEG-fNIRS technology to monitor brain activity in areas linked to pain perception. Sixty patients aged 18 to 75 years with stable heart and lung function and low baseline pain scores will participate to better understand TENS-WAA's neuroregulatory effects on pain during colonoscopy. Participants will be randomly assigned to either the electrical stimulation group or the control group. In the stimulation group, electrodes will be placed on specific ankle zones and deliver electrical currents at the highest comfortable intensity below the pain threshold, with settings of 2 Hz frequency and 500 microseconds pulse width. The control group will have electrodes in the same positions but with minimal current intensity. Both groups will wear EEG-fNIRS devices to monitor brain regions such as the prefrontal cortex, anterior cingulate cortex, motor cortex, and parietal cortex during the procedure. During the study, neural activity data will be collected alongside pain scores measured by the visual analog scale at key points of the colonoscopy. The total time to reach certain colon bends and the ileocecal valve will also be recorded. Researchers will analyze correlations between brain signals and pain perception using advanced statistical models. The study aims to provide new approaches for pain management in unsedated colonoscopy and enhance understanding of TENS-WAA's effects. Participation lasts through the colonoscopy procedure with monitoring during and after.
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Artificial Intelligence in Endoscopic Diagnosis of Colorectal Polyps: A Prospective Randomized Study
Colorectal cancer is the second most common cancer in European Union countries. The main way to detect and prevent colorectal cancer is through colonoscopy, which allows doctors to remove precancerous growths called adenomas and serrated polyps. This research aims to assess how using artificial intelligence (AI) during colonoscopy affects the detection rate of these polyps and early colorectal cancer stages, potentially improving screening quality and reducing cancer risk. Participants are randomly assigned to one of two groups: one group undergoes colonoscopy with the support of the ENDO-AID OIP-1 AI system that helps detect polyps by alerting the doctor in real-time, while the other group has colonoscopy without AI assistance. The AI system uses machine learning algorithms to identify suspicious lesions and mark them on the monitor during the procedure. This study compares the detection rates between these two approaches. During the colonoscopy, researchers measure the adenoma detection rate to evaluate effectiveness. They also assess how useful the AI is for both novice and experienced doctors, analyze the shape of detected polyps, and review the costs associated with using AI over about six months. Participants are followed through the procedure, and outcomes are monitored to understand the impact of AI on colonoscopy quality and colorectal cancer prevention.
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Researchers are evaluating whether the overall adenoma detection rate (ADR) can be a reliable alternative to the screening ADR in colonoscopy procedures. This prospective multicenter study involves 18 colonoscopists from five hospitals in Taiwan and plans to recruit 2,700 participants aged 50 to 80 years over two years. The study includes patients undergoing colonoscopy for screening, surveillance, diagnostic reasons, or positive fecal immunochemical test (FIT) results. The goal is to compare ADRs across these groups and explore correlations between screening ADR and overall ADR including or excluding FIT-positive cases. Participants will be grouped based on their colonoscopy indication: screening (asymptomatic with no or negative prior colonoscopy), surveillance (with prior colon neoplasms), diagnostic (symptomatic or abnormal test findings), and FIT-positive (positive FIT results regardless of recent colonoscopy). The study will compare ADRs using traditional screening definitions and combined indications, including the impact of adding FIT-positive patients to overall ADR calculations. During the study, participants will undergo colonoscopy according to their indication. Researchers will measure the adenoma detection rate within 7 days as the primary outcome. Data collection will include categorizing patients and analyzing ADR correlations. The study will monitor participants throughout the procedure and follow-up as needed, with a total study duration of two years and study completion planned by September 2026.
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Colorectal cancer (CRC) is a common and growing health concern in China, with its incidence increasing faster than the global average. Early detection through screening is crucial to reduce the disease burden, especially in average risk populations where most sporadic cases occur. This trial aims to compare different colorectal cancer screening methods to find effective approaches for the average risk population in China. Participants will be randomly assigned to one of three screening groups: a colonoscopy group that receives a single colonoscopy in the first year; a FIT group that undergoes annual fecal immunochemical tests for four years, with positive results followed by diagnostic colonoscopy; and a FIT plus blood test group that combines annual FIT and blood tests detecting cfDNA methylation, also followed by colonoscopy if positive. All groups will have suspicious lesions removed and examined, followed by annual follow-ups and long-term monitoring. During the study, participants will provide fecal, blood, and tissue samples. Researchers will assess colorectal cancer mortality over 10 years as the primary outcome, along with detection rates of advanced lesions, population compliance, cancer stages, incidence rates, quality of life, and cost-effectiveness over 4 to 10 years. This comprehensive approach includes a 4-year screening phase and extended follow-up to monitor outcomes and safety.
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Healthy Volunteer
This research aims to collect detailed information on treatment methods, outcomes, and side effects during endoscopic procedures for colorectal cancer prevention and treatment. The goal is to see if real-world results match those from targeted clinical studies and current scientific knowledge. Additionally, the study seeks to create training materials for doctors using videos and findings from these procedures, helping medical professionals learn outside of real patient exams. Participants will have diagnostic or therapeutic colonoscopies recorded, with doctors aiming to accurately assess the inside of the body. The study also plans to build a large, updated database of videos, images, and findings accessible to the scientific community to support research and quality assurance. Furthermore, software will be developed to detect and mask sensitive information in videos and reports from about 1,000 examinations. Participants will be involved through their routine colonoscopy procedures, with data such as treatment techniques, complications, and follow-up outcomes tracked over about one year. Researchers will measure how often lesions are completely removed, safety outcomes like complication rates, and follow-up accuracy according to guidelines. The study also monitors procedure times and the need for unexpected re-examinations. This long-term observation aims to improve education, research, and care quality in gastrointestinal endoscopy.
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Researchers are evaluating the effectiveness of 3D colonoscopy compared to standard 2D colonoscopy during surveillance colonoscopy in patients aged 40 and older. The study focuses on improving adenoma detection rate (ADR), which is crucial for preventing colorectal cancer and reducing mortality. Detecting non-polypoid lesions, which are often missed by traditional methods, is a key concern as these lesions contribute to post-colonoscopy colorectal cancer. Participants will be randomly assigned to receive either 3D colonoscopy using a specialized 3D imaging device or standard 2D colonoscopy. This multicenter, prospective, randomized controlled trial compares how well each method detects adenomas and polyps during surveillance colonoscopy performed at least one year after prior colonoscopy and polypectomy. During the study, participants will undergo colonoscopy with monitoring of various detection rates, including overall ADR, flat-ADR, proximal and distal ADR, and polyp detection rates. Researchers will assess adenoma numbers per colonoscopy and evaluate safety and quality of bowel preparation. The primary outcome is the adenoma detection rate within 30 minutes. The study includes double masking to reduce bias and will follow participants until February 2027.
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Healthy Volunteer
Researchers are evaluating the use of sugar-free electrolyte beverages as a replacement for water to dissolve a 2-liter polyethylene glycol (PEG) solution used in bowel preparation before colonoscopy. The study aims to determine if this change can improve the cleanliness of the bowel and increase patient satisfaction during the preparation process. This trial is designed as a single-blind, prospective, multicenter randomized controlled study. Participants are randomly assigned to one of two groups: one uses ordinary drinking water to dissolve the 2L PEG solution, while the other uses the electrolyte beverage called Alienergy as the solvent. By improving the taste and increasing electrolyte content, the study intends to see if patients better tolerate and complete the bowel preparation. The study includes an outpatient colonoscopy preparation period with either solvent. During the study, participants will be assessed using the Boston Bowel Preparation Scale from enrollment until the colonoscopy is completed within a week. Researchers will also measure how palatable the preparation is and the lesion detection rate during colonoscopy. Participants will be monitored for tolerance, adherence, and effectiveness of the bowel cleansing process. The total participation time covers preparation through the colonoscopy procedure and evaluation period.
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