Safety and Feasibility of the Tandem Snare Device

Polyps Clinical Trial

Official title:

Safety and Feasibility of the Tandem Snare Device

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02754050
• Other study ID #: CP-001
• Status: Not yet recruiting
• Phase: N/A
• First received: April 19, 2016
• Last updated: April 25, 2016
• Start date: September 2016
• Est. completion date: October 2018

Study information

• Verified date: April 2016
• Source: Tandem Technologies LTD
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polyps

Intervention

Device:
• Tandem Snare

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tandem Technologies LTD

Outcome

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