Colorectal Cancer Clinical Trial
Official title:
EndoRings™ - Clinical Protocol
Verified date | July 2017 |
Source | EndoAid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this prospective clinical study is to establish the feasibility and usability of the ENDORINGS™ when used during standard colonoscopy procedure.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Israel | Elisha Medical Center | Haifa | Please Select |
Lead Sponsor | Collaborator |
---|---|
EndoAid |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint is reaching the cecum of the colon with the ENDORINGS™. | 24 hours post procedure | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 4. Ease of scope insertion, advancement and withdrawal. | Physician`s subjective evaluation will be recorded in the source documents by a questionnaire. | During procedure | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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