Colorectal Neoplasms Clinical Trial
Official title:
Third Eye Panoramic Device Feasibility Evaluation
Verified date | June 2017 |
Source | Avantis Medical Systems |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the feasibility of using the Third Eye Panoramic device in
conjunction with standard colonoscopes in a clinical setting.
Patients will undergo a colonoscopy procedure during which the study device will provide
video imaging of areas of the colon that are difficult to evaluate with the colonoscope
alone.
The utility of the device will be assessed from the impressions of the investigators and
from telephone follow-up with subjects to assess for post-procedural complications.
Status | Enrolling by invitation |
Enrollment | 40 |
Est. completion date | October 11, 2017 |
Est. primary completion date | October 11, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 75 Years |
Eligibility |
Inclusion Criteria: 1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup. 2. The patient must understand and provide written consent for the procedure. Exclusion Criteria: 1. Patients >75 years of age; 2. Patients with a history of colonic resection; 3. Patients with suspected chronic stricture potentially precluding complete colonoscopy; 4. Patients with diverticulitis or toxic megacolon; 5. Patients with a history of radiation therapy to abdomen or pelvis; 6. 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 |
---|---|---|---|
United States | New York Hospital Queens | Flushing | New York |
Lead Sponsor | Collaborator |
---|---|
Avantis Medical Systems |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Device usability factors | Device usability as measured by investigators' qualitative impressions regarding ease of use and any potential interference with function of colonoscope. | 1 hour (average duration of procedure) | |
Secondary | Device video factors | Video image quality and ability to view areas behind folds as measured by investigators' qualitative impressions | 1 hour (average duration of procedure) | |
Secondary | Patient safety assessed by number of subjects with adverse events as a measure of safety and tolerability | Number of subjects with adverse events | At time of procedure and up to 48 hours after completion of procedure |
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