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NCT02041507 · ClinicalTrials.gov registry record · NA

Water-aided Colonoscopy vs Air Insufflation Colonoscopy in Colorectal Cancer Screening

A NA study of Colorectal Cancer and Pain, sponsored by Presidio Ospedaliero Santa Barbara.

Completed
Registry status
NA
Development phase
1,224
Enrollment target
4
Study locations

NCT02041507: Completed NA study of Colorectal Cancer and Pain, sponsored by Presidio Ospedaliero Santa Barbara.

NCT02041507 is a NA study of Colorectal Cancer and Pain that has completed, run by Presidio Ospedaliero Santa Barbara. The registered enrollment target is 1,224 participants, below the 1,541-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (21% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02041507, a NA study of Colorectal Cancer and Pain, has completed, sponsored by Presidio Ospedaliero Santa Barbara.

COMPLETED
Registry status
NA
Development phase
1,224 participants
Enrollment target
4
Study locations

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

Primary Outcome

Proportion of subjects with at least one adenoma of any size.

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

FieldValue
Enrollment Target 1,224 participants
Start Date 2014-02
Est. Completion 2016-04
Phase NA

What the finished NCT02041507 record still lists

NCT02041507 is an interventional study that assigns participants to a tested intervention. Its 1,224 participants enrollment target places it among the larger protocols in the corpus, below the 1,541-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (21% lower).

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.

NCT02041507 reports a single indexed study location in California, Other, CI.

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.

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).

Who is sponsoring clinical trial NCT02041507?

This trial is sponsored by Presidio Ospedaliero Santa Barbara, which has 5 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Colorectal Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02041507's enrollment target sits among peer trials

1,224 40th of 381 higher than 342 of 381 other Colorectal Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02041507, the US trial registry maintained by the National Library of Medicine. NCT02041507 (large enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.