Clinical trial · Interventional
Clinical Study to Establish the Feasibility and Usability of the EndoRings™
EndoRings™ - Clinical Protocol
NCT01868971CI-TRIAL-00028820completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this prospective clinical study is to establish the feasibility and usability of the ENDORINGS™ when used during standard colonoscopy procedure.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bowel Cancer | Malignant Intestinal Neoplasm | ALIAS | 0.90 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EndoRings | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Colonoscopy procedure with the EndoRings
- description
- Colonoscopy procedure using an add-on device (EndoRings) that is attached to the distal tip of the endoscope
- interventionNames
- Device: EndoRings
Primary outcomes (1)
- measure
- The primary endpoint is reaching the cecum of the colon with the ENDORINGS™.
- timeFrame
- 24 hours post procedure
Secondary outcomes (7)
- measure
- 1. Incidence of complications (number of complications)
- timeFrame
- 24 hours post procedure
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.