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Found 6 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are assessing the safety and effectiveness of the ELIOS device compared to a competitor device in patients with open-angle glaucoma who are undergoing cataract surgery. The main goal is to evaluate how well these devices reduce intraocular pressure IOP 12 months after surgery in adults aged 40 and older with mild to moderate glaucoma. This trial is a prospective, multicenter, randomized clinical study sponsored by Elios Vision, Inc. Participants will undergo cataract surgery using phacoemulsification with intraocular lens implantation. After the cataract surgery, patients will receive treatment with either the ELIOS device or a competitor device, assigned randomly. The study includes two active treatment groups and involves single masking to maintain objectivity. During the study, participants will be monitored at regular intervals for IOP levels at 12 and 24 months, the number of hypotensive medications used, and treated IOP at 12 months. Researchers will track safety and effectiveness through these measures to compare the outcomes between the two devices. The trial is expected to continue until March 2028, with careful follow-up to assess the longer-term effects of treatment.

Age: 40Years +All GendersPhase Not Applicable
16 locations
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Actively Recruiting

Glaucoma is an irreversible optic nerve disease and the second leading cause of blindness worldwide. It can be treated with eye drops, laser, or surgery. Traditional surgery is invasive and carries risks such as hypotonia, infections, and cataracts. To reduce these risks, micro-invasive glaucoma surgeries MIGS have been developed, including the ELIOS laser system, which is specifically designed to treat glaucoma by creating tiny channels in the eyes drainage system to lower intraocular pressure IOP. This study aims to collect data on the effectiveness and safety of the ELIOS laser in combination with cataract surgery to improve patient care. Participants will undergo combined cataract and glaucoma surgery using the ELIOS laser. During the procedure, the surgeon uses the laser probe to create 10 microchannels about 210 micrometers in diameter in the trabecular meshwork and Schlemms canal to enhance fluid drainage from the eye. This micro-invasive laser procedure is performed alongside standard cataract surgery phacoemulsification and typically takes only a few minutes. The ELIOS laser is already in use in France and this study will gather prospective data on its use. Participants will be monitored regularly after surgery with measurements of intraocular pressure on day 0, day 7, day 30, and at 3, 6, and 12 months. Researchers will also assess quality of life before surgery and at 1, 3, 6, and 12 months afterward. The study will track safety and effectiveness over this one-year period to better understand outcomes for glaucoma patients receiving this combined surgery.

Age: 18Years - 80YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are studying patients with pseudoexfoliative glaucoma, a type of glaucoma caused by pseudoexfoliative syndrome, which can make cataract surgery more challenging and prone to complications. This study aims to compare the effectiveness of the Tran cannula, a single-use irrigation device designed to clean pseudoexfoliative material from the eyes drainage system, with increased irrigation using a traditional cannula. The goal is to see which method better lowers eye pressure in patients undergoing cataract surgery who also have glaucoma. Participants will be randomly assigned to one of two groups one treated with the Tran cannula and the other with augmented irrigation using a classical aspiration cannula. Both procedures are done after cataract removal, intraocular implant placement, and viscoelastic aspiration, focusing on cleaning the trabecular meshwork to manage eye pressure. This study uses a double-blind design to fairly compare these two surgical irrigation methods. During the study, researchers will measure intraocular pressure at several key times one day, 30 days, three months, six months, and twelve months after surgery. These measurements will help assess how well each irrigation technique controls eye pressure over time. Participants will be closely monitored throughout the year-long follow-up to evaluate safety and effectiveness of the procedures in managing glaucoma alongside cataract surgery.

Age: 18Years +All GendersPhase Not Applicable
3 locations
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Actively Recruiting

Squamous cell carcinoma of the anus is a rare but increasingly common cancer, often linked to human papillomavirus HPV. For early-stage tumors, combined radiotherapy and chemotherapy with 5FU and mitomycin-C provide good outcomes, but advanced tumors have a poor prognosis with a high relapse rate. Researchers are studying a new approach combining induction chemotherapy with docetaxel, cisplatin, and 5FU mDCF followed by standard chemoradiotherapy to improve treatment results for locally advanced anal cancer T3-4 or N1. This is a randomized phase 3 trial comparing this new strategy to the current standard treatment. The study includes two groups one receives the usual chemoradiotherapy, which involves 33 radiotherapy sessions over 6.5 weeks combined with mitomycin-C and capecitabine chemotherapy taken on radiotherapy days. The other group starts with 4 cycles of mDCF chemotherapy given every two weeks before receiving the same chemoradiotherapy as the control group. Radiotherapy uses intensity-modulated external irradiation with a targeted boost to the tumor and involved lymph nodes. Participants will be followed after treatment with check-ups at 8 weeks, then every 4 months for two years, and every 6 months in the third year. Follow-up includes clinical exams and imaging scans CT and MRI. The main measure of success is disease-related event-free survival two years after treatment. Other outcomes include overall survival, colostomy-free survival, treatment side effects, tumor response, and quality of life. The total study duration for each participant may extend over several years including this follow-up period.

Age: 18Years +All GendersPhase 3
114 locations
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Actively Recruiting

This research aims to screen people who use drugs for hepatitis B, hepatitis C, and AIDS viruses. It focuses on identifying active infections using a simple blood collection method. The study is sponsored by the University Hospital, Rouen, and does not involve experimental drug treatments but diagnostic testing. Participants will have their blood collected using a Dried Blood Spot method, which is a minimally invasive way to collect samples. The study includes individuals who are former or current intravenous or nasal drug users, as well as those on opiate substitution therapy. The screening occurs at the start of participation to detect active infections. Participants will be assessed on the first day for active hepatitis B, hepatitis C, and AIDS infections. The main measurements are the number of individuals found to have active infections of these viruses. This study does not involve any treatment and focuses on diagnostic testing and data collection during the initial visit.

Age: 18Years +All GendersPhase Not Applicable
11 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of fractionated stereotactic radiotherapy FSRT to treat hemorrhagic brain metastases in adults. This Phase 2 trial focuses on patients with recent bleeding within brain metastases and aims to observe complications related to hemorrhage and tumor response after treatment. The study is sponsored by Centre Francois Baclesse and involves patients diagnosed with solid tumors that have spread to the brain. Each brain metastasis, whether hemorrhagic or not, will be treated with FSRT. The treatment consists of delivering a total radiation dose of 30 Gy divided into 3 fractions of 10 Gy each, given over 7 days. Patients eligible for stereotactic radiotherapy are selected by a multidisciplinary committee. The study is conducted in two stages, focusing on patients with specific tumor size and location criteria. Participants will undergo assessments including imaging to monitor for any new or increased bleeding and to evaluate tumor response according to standardized criteria six months after completing radiation therapy. Researchers will also evaluate neurological status, treatment tolerance, and any complications. The total duration of monitoring includes safety and tumor response evaluations at six months post-treatment, with ongoing observation as required by the study protocol.

Age: 18Years +All GendersPhase 2
4 locations