A Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing a Full Spectrum Optical Technology (FUSE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02143284 |
Recruitment Status :
Completed
First Posted : May 21, 2014
Last Update Posted : November 3, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastrointestinal Diseases | Device: Endoscopy exploratory single arm (EndoChoice FUSE(TM) System) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Single-Center, Exploratory Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology |
Study Start Date : | May 2014 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | January 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: Endoscopy exploratory single arm
Exploratory single arm, the system will be used in otherwise standard procedures, and will be reviewed in terms of performance, usability, ease of use and safety.
|
Device: Endoscopy exploratory single arm (EndoChoice FUSE(TM) System)
The investigational device will be applied in otherwise standard procedures (upper and lower Gastrointestinal tract endoscopy) |
- Performance, usability and ease of use [ Time Frame: 1 Year ]The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer.
- Safety [ Time Frame: 1 Year ]The safety of the device will be assessed as a secondary outcome measure according to quantity and nature of adverse and severe adverse events, if such occur.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and Female patients ages of 18-70
- The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance.
- Signed informed consent
Exclusion Criteria:
- Patients with inflammatory bowel disease;
- Patients with a personal history of polyposis syndrome;
- Patients with suspected bowel stricture potentially precluding complete endoscopy
- Patients with a history of diverticulitis or toxic megacolon
- Patients with a history of radiation therapy to neck, abdomen, 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.
- Patients with GI bleeding, that has not been corrected prior to endoscopy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143284
Israel | |
Rambam medical center | |
Haifa, Israel, 31096 |
Principal Investigator: | Ian Gralnek, Prof. | Rambam Medical Center Gastroenterological institute |
Responsible Party: | EndoChoice Innovation Center, Ltd. |
ClinicalTrials.gov Identifier: | NCT02143284 |
Other Study ID Numbers: |
CD-1715 |
First Posted: | May 21, 2014 Key Record Dates |
Last Update Posted: | November 3, 2016 |
Last Verified: | November 2016 |
Gastrointestinal Diseases Digestive System Diseases |