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The purpose of this prospective clinical study is to establish the feasibility and usability of the ENDORINGSâ„¢ 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:
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 ENDORINGSâ„¢.
Secondary Endpoints / Other Outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy procedure with the EndoRings | Other | Colonoscopy procedure using an add-on device (EndoRings) that is attached to the distal tip of the endoscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoRings | Device | Colonoscopy procedure, standard endo-therapy interventions will be performed in accordance with physician's evaluation |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is reaching the cecum of the colon with the ENDORINGSâ„¢. | 24 hours post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Incidence of complications (number of complications) | Known complications include:
A telephone call should be made to the patient at 24 hour post- procedure, to assess post-examination adverse events. |
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Inclusion Criteria:
Any subject who meets all of the following criteria may be included in this study:
Exclusion Criteria:
Any subject who meets any of the following criteria will not be included in this study:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elisha Medical Center | Haifa | Please Select | 34601 | Israel |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D007414 | Intestinal Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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:
| 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 |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |