Clinical trial NCT02754050: Safety and Feasibility of the Tandem Snare Device
Official title: Safety and Feasibility of the Tandem Snare Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polyps
Lead sponsor: Tandem Technologies LTD
Sponsor class: INDUSTRY
First posted: 2016-04-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The colonoscopy procedure is considered the "gold standard" for detecting, diagnosing and treating abnormalities in the colon. Detection and removal of colon polyps is the most significant benefit colonoscopy provides toward the reduction of colorectal cancer mortality and morbidity. 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. The technology may eliminate the repeated bites with the intervention tool or the need to use additional intervention tools such as the net. It may improve visual perception for resecting the polyp without losing it while removing from the colon. Consequently it may increase the potential for complete polypectomy and reduce intervention time and repetitions, polyp lost, risks and cost. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Device related major adverse events
timeFrame: 7 days
measure: Technical success of the Tandem Snare.
timeFrame: 1 day
Secondary outcomes:
measure: Retrieval rate of the polyps that have been cut by the Tandem Snare.
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References: