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Water-aided Colonoscopy vs Air Insufflation Colonoscopy in Colorectal Cancer Screening
NCT02041507 · View on ClinicalTrials.gov ↗
Study Summary
The degree of protection afforded by colonoscopy against proximal colorectal cancer (CRC) appears to be related to the quality of the procedure, and the incomplete removal of lesions has been shown to increase the subsequent risk of developing a colon cancer. Some studies suggest that small polyps with advanced histology are more common in the right than in the left colon (right colon proximal to splenic flexure, left colon distal to the splenic flexure). The average size of polyps in the right colon with advanced pathology or containing adenocarcinoma was ≤9 mm, whereas in the left colon their average size was \>9 mm, P\<0.001. Inadequate prevention of right-sided CRC incidence and mortality may be due to right-sided polyps with advanced histology or that harbor malignancy. These presumptive precursors of cancer are smaller and possibly more easily obscured by residual feces, and more likely to be missed at colonoscopy. Water-aided colonoscopy (WAC) can be subdivided broadly into two major categories: water immersion (WI), characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy, and water exchange (WE), characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy. In some reports WE appeared to be superior to both WI and air insufflation colonoscopy (AI) in terms of pain reduction and adenoma detection, particularly for \<10 mm adenomas in the proximal colon. In this multicenter, double-blinded randomized controlled trial (RCT) we test the hypothesis that that WE, compared to AI and WI, will enhance overall Adenoma Detection Rate (ADR) in CRC screening patients. Confirmation of the primary hypothesis will provide evidence that WE enhances the quality of screening colonoscopy. We also hypothesize that WE may be more effective in detecting proximal colon adenomas than WI and AI, particularly \<10 mm adenomas, thus increasing proximal colon ADR and proximal colon A
Conditions Studied
Interventions
- OTHER Air insufflation method.
- OTHER Water Immersion method.
- OTHER Water Exchange method.
Study Locations (4)
California
- Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System — Los Angeles
Other
- Digestive Diseases Center, Vìtkovice Hospital — Ostrava
CI
- Digestive Endoscopy Unit, Ospedale S. Barbara — Iglesias
CO
- Division of Gastroenterology, Ospedale Valduce — Como
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,224 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02041507
The ClinicalTrials.gov registry entry for NCT02041507 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,224 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Presidio Ospedaliero Santa Barbara, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions — of which Air insufflation method. is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02041507 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Other, CI. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02041507 about?
NCT02041507 is a clinical study titled "Water-aided Colonoscopy vs Air Insufflation Colonoscopy in Colorectal Cancer Screening". The degree of protection afforded by colonoscopy against proximal colorectal cancer (CRC) appears to be related to the quality of the procedure, and the incomplete removal of lesions has been shown to increase the subsequent risk of developing a colon cancer. Some studies suggest that small polyps ...
What is the current status of trial NCT02041507?
This trial is currently completed. It is a NA study. The enrollment target is 1,224 participants. The study started on 2014-02. Estimated completion is 2016-04.
What conditions does trial NCT02041507 study?
This clinical trial studies the following conditions: Colorectal Cancer, Pain, Colorectal Polyps, Colorectal Adenomas. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02041507?
The interventions under investigation include: Air insufflation method. (OTHER), Water Immersion method. (OTHER), Water Exchange method. (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02041507?
This trial is sponsored by Presidio Ospedaliero Santa Barbara, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02041507 being conducted?
This trial has 4 study locations across California, CI, CO. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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