Endocuff for Surveillance of Serrated Polyposis Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-07-31

Brief Summary

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Serrated Polyposis Syndrome (SPS) is a high-risk condition for colorectal cancer (CRC). SPS patients have a cumulative CRC risk of 1.9% in 5 years despite a strict endoscopic surveillance in specialized centers. Proximal serrated lesions are endoscopically challenging to detect due to their unremarkable morphology. Endocuff is a novel device comprised of a cap with a row of finger-like projections with a unique dynamic shape that help to flatten mucosal folds during withdrawal of the instrument in order to improve detection of lesions. Recent studies have reported an increase of detection rate and mean per patient of adenomas with Endocuff-assisted Colonoscopy compared with Standard Colonoscopy. The purpose of this study is to assess the usefulness of Endocuff-assisted Colonoscopy to detect serrated lesions in SPS patients undergoing surveillance compared to Standard Colonoscopy in a randomized fashion

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Detailed Description

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According to own data and similarly to previous published studies, patients diagnosed of Serrated Polyposis Syndrome undergoing annual surveillance after clearance of all serrated lesions ≥ 5mm, have a mean of 5 serrated lesions per patient at follow-up colonoscopies. The study was powered to establish a 25% significant increase in the mean of serrated lesions per patient in the Endocuff-assisted colonoscopy group. Accepting an alpha risk of 0.05, a beta risk of 0.2 and a loss rate of 10% in a bilateral contrast, a sample size of 124 patients (62 in each arm) are required to achieve statistic significance.

Conditions

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Polyposis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Endocuff-assisted Colonoscopy

Endocuff-assisted Colonoscopy with the ARC Endocuff-vision® attached at the distal tip of the scope.

Group Type ACTIVE_COMPARATOR

Endocuff-assisted Colonoscopy

Intervention Type DEVICE

Colonic examination with Endocuff-assisted Colonoscopy

Standard Colonoscopy

Standard Colonoscopy without any additional device

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Endocuff-assisted Colonoscopy

Colonic examination with Endocuff-assisted Colonoscopy

Intervention Type DEVICE

Other Intervention Names

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ECC

Eligibility Criteria

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Inclusion Criteria

-Adults with diagnosis of Serrated Polyposis Syndrome undergoing surveillance colonoscopies after clearance of all lesions \>=5mm

Exclusion Criteria

* Patients with known strictures
* Partial or total colonic resection
* Acute diverticulitis
* Concomitant inflammatory bowel disease
* Suspected or proven lower gastrointestinal bleeding
* Non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure
* Inability to sign informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No