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

NCT ID: NCT01868971

Last Updated: 2017-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-10-31

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.

Detailed Description

The EndoAid Ltd. EndoRings is used during endoscopy procedures. The EndoRings is a short silicon rubber tube with flexible circular wings that attaches to the distal end of the endoscope to facilitate endoscopic therapy.

The EndoRings is designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following ETO sterilization and is single use only.

Indications for Use:

To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:

• Keeping the suitable depth of endoscope's view field
• Helping the endoscope with being inserted into the gastrointestinal tract

Patient Population: The study population is comprised of patients indicated for colonoscopy.

Study Design: Single-center study. A single treatment group of 60 patients. No. of Patients: Up to sixty (60) treated patients will be enrolled in the study.

Primary Endpoints:The primary endpoint is reaching the cecum of the colon with the ENDORINGS™.

Secondary Endpoints / Other Outcomes:

1. Incidence of complications (number of complications)

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

3. Procedure time.

4. Ease of scope insertion, advancement and withdrawal.

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

6. Subjective evaluation of the additional area screened by the physician (recorded in the source documents by a questionnaire).

7. Patient satisfactory (by a follow up phone-call in which questionnaire with VAS scale will be filled out).

Conditions

Colon Cancer; Bowel Cancer; Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Colonoscopy procedure with the EndoRings

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

Group Type: OTHER

EndoRings

Intervention Type: DEVICE

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

Interventions

EndoRings

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EndoAid

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Gralnek, Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Elisha Medical Center

Haifa, Please Select, Israel

Countries

Israel

Other Identifiers

CSDPR100

Identifier Type: -

Identifier Source: org_study_id