Actively Recruiting
Exploratory Study on Remote Robot-Assisted Laparoscopic Surgery Using 5G for Gynecological Cancer Treatment
Led by Affiliated Hospital of Nantong University · Updated on 2025-01-28
5
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating remote robot-assisted laparoscopic surgery for gynecological surgical treatment using a 5G network. This exploratory clinical study aims to study the safety and effectiveness of this new approach in patients who need endoscopic surgery. It is a single-center, single-arm study designed to better understand how this technology works in gynecological cancer treatment. The treatment involves using the Toumai laparoscopic surgical system combined with 5G communication technology to perform remote surgical procedures. The study includes three stages: screening, treatment, and follow-up. During screening, patients who meet the criteria and consent to participate are enrolled. The treatment phase applies the laparoscopic system through 5G networks for surgery. Follow-up lasts up to one month after surgery and may be extended if needed to observe safety and efficacy. Participants will undergo various medical observations and examinations throughout the study to assess surgical complications and other safety indicators. Clinical data and previous medical results will be collected at screening. The primary outcome measure is tracking surgical complications from enrollment up to one month after surgery, with assessment possibly extending to six months. This study lasts from screening through follow-up to ensure thorough monitoring of participant health and treatment effects.
CONDITIONS
Brief Title
Laparoscopic Surgical Systems for Gynecological and Remote Surgical Treatment.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who require endoscopic surgery
- Voluntarily participate in this study and sign informed consent in writing
You will not qualify if you...
- Patients with malignant tumors with clinical stage IV
- Those who require emergency surgery
- Presence of active bleeding, severe abnormal coagulopathy (prothrombin time (PT) or international normalized ratio (INR) greater than 1.5 times the upper limit of normal), or platelet count < 80×10^9/L
- Patient has severe cardiovascular or circulatory disease and cannot tolerate surgery
- Participated in other clinical trials in the past 1 month
- Inability to understand trial requirements, or inability to complete the study follow-up plan
- Other conditions that are considered by the investigator to be inappropriate for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Day of surgery
Participants undergo laparoscopic surgery using a remote robot-assisted system connected via 5G network for gynecological treatment.
1 surgical visit (in-person)
Duration - Up to 1 month or longer if needed
Physician-observed follow-up to monitor safety and effectiveness after surgery, continuing up to one month post-surgery and possibly extended if necessary.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
Actively Recruiting
Research Team
M
Minhui Hua, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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