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Adenoma

Polyps

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Cola

Colonoscopy is performed with the EndoRings attached

Standard colonoscopy without any additional devices

EndoRings

Standard colonoscopy

Tobias Meister, Prof. Dr.

Ralf Kiesslich, Prof. Dr.

Volker Ellenrieder, Professor

Detlev Ameis, Prof.Dr.med.

Tobias Meister, M.D.

Martin Floer, M.D.

Döner Ufuk

Michael Schepke, Prof.Dr.med.

Adenoma detection rate (ADR) in colon cancer screening is most important for avoiding colon cancer development. Recent studies suggest a benefit of endoscopic devices attached to the distal tip of the colonoscope for improving the ADR. This work is the first GERMAN randomized controlled trial comparing standard colonoscopy with EndoRIngs-assisted colonoscopy.

EndoRings is a new FDA approved device that is attached to the distal tip of the colonoscope. Better Polyp detection is suspected by flattening the mucosal folds during withdrawal

EndoRings Colonoscopy for Adenoma Detection

EndoRings Versus Standard Colonoscopy for Adenoma Detection

Helios Albert-Schweitzer-Klinik Northeim

Digestive System Diseases

Colorectal Neoplasms

Colonic Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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

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

Ian Gralnek, Prof.

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

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).

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

EndoRings™ - Clinical Protocol

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.

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.

Procedural times for each colonoscopy procedure:

1. Time for intubation to the cecum
2. Time for withdrawal from the cecum to the anal verge
3. Total procedure time

Physician's subjective evaluation will be recorded in the source documents by a questionnaire.

A telephone call should be made to the patient at 24 hour post- procedure, to assess patient satisfactory by completing a VAS scale questionnaire.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EndoRings Colonoscopy for Adenoma Detection	NCT03469622	Adenoma	EndoRings Standard colono...	45 Years -	Helios Albert-Schweitzer-Klinik Northeim
EndoRings Colonoscopy for Adenoma Detection	NCT03469622	Adenoma	EndoRings Standard colono...	45 Years -	Helios Albert-Schweitzer-Klinik Northeim
EndoRings Colonoscopy for Adenoma Detection	NCT03469622	Adenoma	EndoRings Standard colono...	45 Years -	Helios Albert-Schweitzer-Klinik Northeim
Clinical Study to Establish the Feasibility and Usability of the EndoRings™	NCT01868971	Colon Cancer Bowel Cancer Colorectal Canc...	EndoRings	18 Years - 70 Years	EndoAid

Spots Global Cancer Trial Database for endorings

Every month we try and update this database with for endorings cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for endorings

Every month we try and update this database with for endorings cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for endorings cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.