Polyps Clinical Trial
Official title:
Safety and Feasibility of the Tandem Snare Device
Verified date | April 2016 |
Source | Tandem Technologies LTD |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
The device is intended to endoscopically transect polyps in the gastrointestinal tract (sessile or pedunculated) using electrocautery. During the same maneuver the polyp is captured, retrieved and submitted for pathological analysis. The Tandem Snare is an intervention tool inserted through the colonoscope for the resection and removal of polyps sized 6 to 25 mm. The Tandem snare utilizes a technology that has the potential to hold the polyp, lift it up, resect and remove it without losing it. This is a feasibility study aiming to demonstrate the safety of the Tandem Snare used for 6-25mm polyps' polypectomy in screening, diagnostic or surveillance colonoscopy.
Status | Not yet recruiting |
Enrollment | 12 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adults > 18 Years 2. Subjects have been scheduled for colonoscopy 3. Subject has signed the informed consent Exclusion Criteria: 1. Suspected or known active Inflammatory Bowel Disease (IBD) 2. Coagulopathy or thrombocytopenia. 3. Taking dual anti platelet therapy or anti coagulants. 4. Bowel preparation is deemed poor by colonoscopist. 5. Subjects with known or detected (during colonoscopy) moderate/severe diverticular disease. 6. History of familial polyposis (FAP). 7. History of prior surgery to colon and/or rectum. 8. ASA = IV. 9. Pregnancy (as stated by patient). 10. Subjects with altered mental status/inability to provide informed consent. 11. Patients who have participated in another interventional clinical study in the last month. 12. Subject under a condition which in the investigators opinion may put the subject at significant risk, confound study results, or interfere significantly. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tandem Technologies LTD |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Device related major adverse events | Device related major adverse events include death, major bleeding or perforation) | 7 days | Yes |
Primary | Technical success of the Tandem Snare. | The primary feasibility assessment will be encountered as success if the Tandem Snare was inserted through the working channel, cut the polyp and the device was successfully removed from the working channel. | 1 day | No |
Secondary | Retrieval rate of the polyps that have been cut by the Tandem Snare. | The secondary performance assessment will be based on data from all polyps which were resected by the Tandem Snare. Retrieval of the resected polyp will be encountered as success, | 1 day | No |
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