Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments
1 other identifier
interventional
126
1 country
1
Brief Summary
The goal of this study is to compare two FDA approved distal colonoscope attachment devices, in order to identify which device can increase adenoma detection rate the most without increasing procedure time or risk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 25, 2016
CompletedFirst Posted
Study publicly available on registry
January 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedResults Posted
Study results publicly available
June 18, 2020
CompletedJune 18, 2020
June 1, 2020
1.1 years
January 25, 2016
April 15, 2019
June 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adenoma Detection Rate
The investigators will compare adenoma detection rate at completion of study across the 3 arms
Completion of procedure
Secondary Outcomes (3)
Proximal Adenoma Detection Rate
Completion of procedure
Cecal Intubation Rate
Completion of procedure
Withdrawal Time
Completion of procedure
Study Arms (3)
Control
OTHERStandard colonoscopy - no distal colonoscope attachment will be used in this arm
Olympus transparent cap
EXPERIMENTALThe Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure
Medivators Endocuff
EXPERIMENTALThe Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure
Interventions
Eligibility Criteria
You may qualify if:
- At least 50 years old
- Presenting for a screening or surveillance colonoscopy at UC Davis Endoscopy Suites
You may not qualify if:
- Age less than 50 years
- Prior history of colon cancer
- Patients with inflammatory bowel disease
- Patients suspected to have colon cancer based on non invasive tests such as stool tests for hemoglobin or DNA, or imaging finding suggestive of colon cancer (CT or barium enema).
- Patients undergoing colonoscopy for evaluation of symptoms such as abdominal pain, rectal bleeding, diarrhea, constipation, etc, or patient with iron deficiency anemia suspected to be due to ongoing bleeding inside the colon
- Patients with family history of colon cancer in 1st degree relative below the age of 60
- Patients with family history of hereditary polyposis syndromes such as Lynch syndrome, familial adenomatous polyposis etc, which are associated with an increased risk of colon cancer
- Patients unable to consent
- Pregnant patients
- Incarcerated patients
- Non-English speakers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Davis
Sacramento, California, 95817, United States
Related Publications (4)
Brenner H, Hoffmeister M, Arndt V, Stegmaier C, Altenhofen L, Haug U. Protection from right- and left-sided colorectal neoplasms after colonoscopy: population-based study. J Natl Cancer Inst. 2010 Jan 20;102(2):89-95. doi: 10.1093/jnci/djp436. Epub 2009 Dec 30.
PMID: 20042716BACKGROUNDPioche M, Matsumoto M, Takamaru H, Sakamoto T, Nakajima T, Matsuda T, Abe S, Kakugawa Y, Otake Y, Saito Y. Endocuff-assisted colonoscopy increases polyp detection rate: a simulated randomized study involving an anatomic colorectal model and 32 international endoscopists. Surg Endosc. 2016 Jan;30(1):288-95. doi: 10.1007/s00464-015-4208-8. Epub 2015 Apr 11.
PMID: 25861907BACKGROUNDWestwood DA, Alexakis N, Connor SJ. Transparent cap-assisted colonoscopy versus standard adult colonoscopy: a systematic review and meta-analysis. Dis Colon Rectum. 2012 Feb;55(2):218-25. doi: 10.1097/DCR.0b013e31823461ef.
PMID: 22228167BACKGROUNDHarada Y, Hirasawa D, Fujita N, Noda Y, Kobayashi G, Ishida K, Yonechi M, Ito K, Suzuki T, Sugawara T, Horaguchi J, Takasawa O, Obana T, Oohira T, Onochi K, Kanno Y, Kuroha M, Iwai W. Impact of a transparent hood on the performance of total colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):637-44. doi: 10.1016/j.gie.2008.08.029.
PMID: 19251004BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sooraj Tejaswi
- Organization
- University of California, Davis
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2016
First Posted
January 28, 2016
Study Start
January 1, 2016
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
June 18, 2020
Results First Posted
June 18, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share