Safety and Feasibility of the Tandem Snare Device

NCT02754050 | Unknown

• 1 other identifier: CP-001
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polyps

Outcome Measures

Primary Outcomes (2)

• Device related major adverse events

  Device related major adverse events include death, major bleeding or perforation)

  7 days

• 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

Secondary Outcomes (1)

• Retrieval rate of the polyps that have been cut by the Tandem Snare.

  1 day

Study Arms (1)

Polypectomy

EXPERIMENTAL

When a 6-25mm polyp is identified the Tandem snare will be inserted through the colonoscope, remove and retrieve the polyp.

Device: Tandem Snare

Interventions

Tandem Snare DEVICE

Polypectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \> 18 Years
• Subjects have been scheduled for colonoscopy
• Subject has signed the informed consent

You may not qualify if:

• Suspected or known active Inflammatory Bowel Disease (IBD)
• Coagulopathy or thrombocytopenia.
• Taking dual anti platelet therapy or anti coagulants.
• Bowel preparation is deemed poor by colonoscopist.
• Subjects with known or detected (during colonoscopy) moderate/severe diverticular disease.
• History of familial polyposis (FAP).
• History of prior surgery to colon and/or rectum.
• ASA ≥ IV.
• Pregnancy (as stated by patient).
• Subjects with altered mental status/inability to provide informed consent.
• Patients who have participated in another interventional clinical study in the last month.
• Subject under a condition which in the investigators opinion may put the subject at significant risk, confound study results, or interfere significantly.

Sponsors & Collaborators

• Tandem Technologies LTD: lead

MeSH Terms

Conditions

Polyps

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 28, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: April 28, 2016

Record last verified: 2016-04