Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Colorectal cancer is a major cause of morbidity and mortality in Western countries. Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC incidence and mortality.

Endoscopic polypectomy carries a risk of major complications, such as bleeding or bowel perforation, so that a careful balance between efficacy and safety appears to be clinically relevant.

Most of the polypectomies are performed for diminutive (\<5 mm) or small (6-9 mm) lesions, which represent over 90% of all the polyps.

To minimize the risk of complications when removing \<10 mm polyps, cold-polypectomy techniques - i.e. without electric current - by means of biopsy forceps or snare, have been proposed.

Although the risk of perforation is virtually excluded by cold-polypectomy, the lack of electrocautery may result in an increased risk of bleeding. The safety of cold-snare polypectomy has however been recently shown in controlled trials.

Regarding the efficacy of cold-polypectomy for subcentimetric polyps, very few studies have assessed the post-polypectomy completeness of the removal of polyp tissue (i.e. residual disease), and no studies have compared it to conventional polypectomy.

The investigators perform this study to assess both the efficacy and safety of a novel snare (Exacto™) for polyp removal.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effectiveness of an Exclusive Cold Snare Polypectomy Snare for the Removal of Diminutive Colorectal Polyps

NCT02036047

Diminutive Colorectal Polyp Cold Snare Polypectomy Polypectomy Snare +2 more

COMPLETED NA

Comparison Rectal Endoscopic Submucosal Dissection to Endoscopic Mucosal Resection

NCT02198729

Colonic Polyps

COMPLETED NA

Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps

NCT01646242

Polyp of Large Intestine

COMPLETED PHASE4

Efficacy of EndoClot™ Spraying After Endoscopic Resection of Large Colorectal Polyps

NCT05029934

Wound Endoscopical, Colon After Polyp Resection, Colon

TERMINATED NA

Does Routine Submucosal Injection Improve Complete Resection of 4-20 mm Neoplastic Colorectal Polyps?

NCT04548947

Colorectal Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polyp of Large Intestine Colonic Polyps Colon Nos Polypectomy Tubular Adenoma Complications Bleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Colonic polyps

Exacto™

Group Type EXPERIMENTAL

Exacto™

Intervention Type DEVICE

Cold snare polypectomy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exacto™

Cold snare polypectomy

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All consecutive patients undergoing colonoscopy, with at least one and no more than 5 polyps \<10 mm.
* The patient is at satisfactory risk to undergo abdominal surgery.
* The patient must understand and provide written consent for the procedure.

Exclusion Criteria

* Patients with inflammatory bowel disease.
* Patients undergoing standard snare resection (with cautery) of polyps larger than 10 mm.
* Patients with a personal history of polyposis syndrome.
* Patients with suspected chronic stricture potentially precluding complete colonoscopy.
* Patients with diverticulitis or toxic megacolon.
* Patients with a history of radiation therapy to abdomen or pelvis.
* Patients with a history of severe cardiovascular, pulmonary, liver or renal disease.
* Personal history of coagulation disorders or use of anticoagulants/clopidogrel/aspirin/ticlopidine.
* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No