A Prospective Randomized Comparison of the Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®)

NCT03442738 | Completed

• 1 other identifier: PV 5294
• Study Type: observational
• Target: 1,382
• Locations: 1 country
• Sites: 9

Brief Summary

The aim of this study is to evaluate the effect of ENDOCUFF VISION® (caps with soft, about 1 cm long lateral feet of rubber ("Endocuff") to flatten the colon folds) on ADR in a real-life setting (general practices) and in a homogenous patient collective (screening colonoscopies only). It is a prospective randomized multi centric study, with participation of at least 10 study sites (private practice). The study is an inverstigator-initiated trial (IIT). Depending on the randomization (closed envelope), the patients are examined with the standard instruments without or with ENDOCUFF VISION®. Group 1: screening colonoscopy with standard colonoscopes with ENDOCUFF VISION® Group 2: screening colonoscopy with standard colonoscopes without cap

Conditions

Adenoma Detection Rate

Keywords

ADR; adenoma; polyp; colon; screening; colorectal carcinoma (CRC); cap; endoscopy; colonoscopy; private practice

Outcome Measures

Primary Outcomes (1)

• Adenoma Detection Rate (ADR) in the two study groups

  Differences in ADR with or without the new disposable ENDOCUFF VISION® cap. Hypothesis: Endocuff Vision improves the adenoma detection rate (ADR) by about 25% compared to the comparison group.

  through study completion, an average of 1 year

Secondary Outcomes (9)

• ADR (all adenoma/all patients)

  12 months

• assessment of adenoma subgroups by location

  12 months

• assessment of adenoma subgroups by size

  12 months

• assessment of adenoma subgroups by form

  12 months

• assessment of adenoma subgroups by histology

  12 months

Study Arms (2)

Group I Endocuff group

Group I Endocuff cap use

Procedure: Endocuff group

Group II standard colonoscope

Group II standard colonoscope, no further device used

Procedure: Endocuff group

Interventions

Endocuff group PROCEDURE

Endocuff Vision cap on Standard colonoscope

Group I Endocuff group; Group II standard colonoscope

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Screening Population for Adenoma and CRC

You may qualify if:

• \> 55 years
• who voluntarily undergo a screening colonoscopy
• information and signed declaration of consent

You may not qualify if:

• symptoms that may indicate a colonic disease
• rectal/colonic bleeding
• known colon disease for further diagnosis, e.g. Carcinoma, polyps for erosion, inflammatory bowel disease, stenosis
• follow-up/surveillance after colon carcinoma surgery or polypectomy
• anticoagulant drugs that make a biopsy or polypectomy impossible
• poor general condition (from ASA (American Society of Anesthesiologists Classification) III)
• partial/incomplete colonoscopy planned

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Norgine: collaborator

Study Sites (9)

Gastroenterologische Spezialpraxis am Wittenbergplatz

Berlin, 10318, Germany

Location

Gemeinschaftspraxis Hohenzollerndamm

Berlin, 10713, Germany

Location

Gastroenterologie am Bayerischen Platz

Berlin, 10825, Germany

Location

Praxis Dr. Mayr

Berlin, 12163, Germany

Location

Praxis für Gastroenterologie in Berlin Reinickendorf

Berlin, 13437, Germany

Location

Praxis Dr. med. Jens Aschenbeck

Berlin, 13581, Germany

Location

Gastropraxis Eppendorfer Baum

Hamburg, 20249, Germany

Location

Schwerpunktpraxis CCB Bergedorf

Hamburg, 21029, Germany

Location

Magen-Darm-Zentrum, Facharztzentrum Eppendorf

Hamburg, Germany

Location

Related Publications (21)

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  PMID: 36030888 DERIVED

MeSH Terms

Conditions

Adenoma; Polyps; Colorectal Neoplasms; Anterior polar cataract 2

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Thomas Rösch

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 22, 2018
• Study Start: September 1, 2017
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2022
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (9)