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

EndoRings™ - Clinical Protocol

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colon Cancer; Bowel Cancer
• Intervention / Treatment: Device: EndoRings

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Please Select
    • Haifa, Please Select, Israel, 34601
      • Elisha Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Colonoscopy procedure with the EndoRings; Colonoscopy procedure using an add-on device (EndoRings) that is attached to the distal tip of the endoscope	Device: EndoRings; Colonoscopy procedure, standard endo-therapy interventions will be performed in accordance with physician's evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary endpoint is reaching the cecum of the colon with the ENDORINGS™.	24 hours post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Incidence of complications (number of complications)	Known complications include: Perforation;; Severe abdominal pain;; Infection;; Bleeding (other than expected minor bleeding due to therapeutic procedures e.g. polypectomy);; Inducing inflammation of diverticulum; Arrhythmia, bradycardia, hypotension, hypoxia; Death A complication is defined as any one of the above complications as well as any other unexpected complication requiring medical intervention beyond that of the standard procedure. All adverse events will be reported and treated as per the standard clinical practices. A telephone call should be made to the patient at 24 hour post- procedure, to assess post-examination adverse events.	24 hours post procedure
2. Ability to complete s therapeutic interventions as biopsies, polypectomies, APC etc.	Whenever a polyp or other abnormality is detected, the endoscopist will perform biopsy, polypectomy or other evaluation or therapy as appropriate. The clinical investigator will use his/her clinical judgment on the safety of polyp removal/biopsy.	24 hours post procedure
3. Procedure time.	Procedural times for each colonoscopy procedure: Time for intubation to the cecum; Time for withdrawal from the cecum to the anal verge; Total procedure time	During procedure
4. Ease of scope insertion, advancement and withdrawal.	Physician's subjective evaluation will be recorded in the source documents by a questionnaire.	During procedure
5. Ability to center the scope inside the gastrointestinal tract.	Physician's subjective evaluation will be recorded in the source documents by a questionnaire.	During procedure
6. Subjective evaluation of the additional area screened by the physician.	Physician's subjective evaluation will be recorded in the source documents by a questionnaire.	During procedure
7. Patient satisfactory.	A telephone call should be made to the patient at 24 hour post- procedure, to assess patient satisfactory by completing a VAS scale questionnaire.	During procedure

Collaborators and Investigators

• Sponsor: EndoAid
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: May 29, 2013
• First Submitted That Met QC Criteria: May 31, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: EndoRings
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: CSDPR100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No