Clinical trial NCT01868971: Clinical Study to Establish the Feasibility and Usability of the EndoRings™
Official title: EndoRings™ - Clinical Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Bowel Cancer
Colorectal Cancer
Keywords: EndoRings
Lead sponsor: EndoAid
Sponsor class: INDUSTRY
First posted: 2013-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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).

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.

Primary outcomes:
measure: The primary endpoint is reaching the cecum of the colon with the ENDORINGS™.
timeFrame: 24 hours post procedure
Secondary outcomes:
measure: 1. Incidence of complications (number of complications)
timeFrame: 24 hours post procedure
measure: 2. Ability to complete s therapeutic interventions as biopsies, polypectomies, APC etc.
timeFrame: 24 hours post procedure
measure: 3. Procedure time.
timeFrame: During procedure
measure: 4. Ease of scope insertion, advancement and withdrawal.
timeFrame: During procedure
measure: 5. Ability to center the scope inside the gastrointestinal tract.
timeFrame: During procedure
measure: 6. Subjective evaluation of the additional area screened by the physician.
timeFrame: During procedure
measure: 7. Patient satisfactory.
timeFrame: During procedure
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Elisha Medical Center
state: Please Select
Study officials:
affiliation: 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
name: Ian Gralnek, Prof.
role: PRINCIPAL_INVESTIGATOR
References: