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New treatment option for Endoscopic Mucosal Resection
Official title Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System
ClinicalTrials.gov ID: NCT07315893
What this study is testing
- What it's testing
- The objective of this clinical study is to assess the safety of the Su2ura® GI system when used for endoscopic suturing and soft-tissue approximation in patients referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric neoplastic lesions. The main questions it aims to answer are: 1.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Patient is able to provide informed consent .
- Body mass index (BMI) 20-40 kg/m2
- Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of a gastric neoplastic lesion
- Candidate for endoscopic defect closure based on the operating's endoscopist assessment.
You likely can't join if
- Patient with severe comorbidities likely to limit survival to less than 2 years.
- Patients with INR\>1.5
- Patients with PLT\< 150
- Patient with known collagen or connective tissue disorders (e.g. scleroderma, marfan syndrome) .
- Pregnant women or those intending to become pregnant during the study period
- Patient with ascites on physical examination or CT scan.
See the full eligibility criteria
- Age ≥18 years
- Patient is able to provide informed consent .
- Body mass index (BMI) 20-40 kg/m2
- Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of a gastric neoplastic lesion
- Candidate for endoscopic defect closure based on the operating's endoscopist assessment.
- Patient with severe comorbidities likely to limit survival to less than 2 years.
- Patients with INR\>1.5
- Patients with PLT\< 150
- Patient with known collagen or connective tissue disorders (e.g. scleroderma, marfan syndrome) .
- Pregnant women or those intending to become pregnant during the study period
- Patient with ascites on physical examination or CT scan.
- Patient with varices.
- Patient on peritoneal dialysis.
- Patient with wound-healing disorders.
- Patient with significant coagulation disorders or those requiring anti thrombotic or anticoagulation treatment other than aspirin .
- Patient with autoimmune disorder requiring more than 10 mg of corticosteroid daily .
- Patients in need of immunomodulatory therapy.
- Immunocompromised patients (e.g., HIV/AIDS, organ transplant, chemo- or radiation therapy 6 months prior to recruitment).
- Patient in need of concomitant surgical procedures other than those permitted in the protocol.
- Non-compliance with the study protocol.
- Patient requests to exist the study. -
The study team makes the final eligibility decision.
Where it's taking place
- Tel Aviv, Israel
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tel Aviv, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.