Clinical Study to Establish the Feasibility and Usability of the EndoRings™

NCT01868971 | Completed DMC

• 1 other identifier: CSDPR100
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective clinical study is to establish the feasibility and usability of the ENDORINGS™ when used during standard colonoscopy procedure.

Conditions

Colon Cancer; Bowel Cancer; Colorectal Cancer

Keywords

EndoRings

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is reaching the cecum of the colon with the ENDORINGS™.

  24 hours post procedure

Secondary Outcomes (7)

• 1. Incidence of complications (number of complications)

  24 hours post procedure

• 2. Ability to complete s therapeutic interventions as biopsies, polypectomies, APC etc.

  24 hours post procedure

• 3. Procedure time.

  During procedure

• 4. Ease of scope insertion, advancement and withdrawal.

  During procedure

• 5. Ability to center the scope inside the gastrointestinal tract.

  During procedure

Study Arms (1)

Colonoscopy procedure with the EndoRings

OTHER

Colonoscopy procedure using an add-on device (EndoRings) that is attached to the distal tip of the endoscope

Device: EndoRings

Interventions

EndoRings DEVICE

Colonoscopy procedure, standard endo-therapy interventions will be performed in accordance with physician's evaluation

Colonoscopy procedure with the EndoRings

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any subject who meets all of the following criteria may be included in this study:
• Subject between the ages of 18 and 70
• The patient is undergoing colonoscopy for screening, or for surveillance in follow-up of previous polypectomy or for diagnostic workup;
• Written informed consent must be available before enrollment in the trial
• For women with childbearing potential, adequate contraception

You may not qualify if:

• Any subject who meets any of the following criteria will not be included in this study:
• Patients with a history of colonic resection;
• Patients with inflammatory bowel disease;
• 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 who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Sponsors & Collaborators

• EndoAid: lead

Study Sites (1)

Elisha Medical Center

Haifa, Please Select, 34601, Israel

Location

MeSH Terms

Conditions

Colonic Neoplasms; Intestinal Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ian Gralnek, Prof.

  Attending Physician at Elisha Hospital, Haifa, Israel ~~~~~ Chief, Hospital-Wide Ambulatory Care Services Head, GI Outcomes Unit and Senior Physician Department of Gastroenterology Rambam Health Care Campus Rappaport Faculty of Medicine, Technion-Israel

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 5, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

IL (1)