Adenoma Detection Rate in Colonoscopy Performed With EndoRings

NCT03219918 | Terminated DMC

• 1 other identifier: ZUH-KØGE-KIR1
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to examine whether colonoscopy using an EndoRings cap has a higher adenoma detection rate than conventional colonoscopy. Secondary end-points is to compare completion rate, completion time, complication rate and detection of malignancies. Half of the patients will be randomised to colonoscopy using cap and the other half to no cap.

Conditions

Colorectal Adenoma; Colorectal Neoplasms

Keywords

Colorectal adenoma; Colonoscopy; Caps; Adenoma detection rate

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  Number of colorectal adenomas/neoplasms/carcinomas found in colonoscopy

  maximum 60 minutes

Secondary Outcomes (3)

• Completion time

  maximum 60 minutes

• Completion rate

  maximum 60 minutes

• Malignancy detection

  maximum 60 minutes

Study Arms (2)

With EndoRings

ACTIVE COMPARATOR

Colonoscopy is performed with the use of the cap-device EndoRings II Distal Attachment to be attached to the tip of the colonoscope

Device: EndoRings II Distal Attachment

NO EndoRings

NO INTERVENTION

Colonoscopy is performed conventionally without any caps

Interventions

EndoRings II Distal Attachment DEVICE

Colonoscopy cap

With EndoRings

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 50 - 74 years (age range of screening population)
• Positive HemoCult home test from the Danish Colorectal Cancer Screening Programme
• Ability to give informed consent to participation in the trial.

You may not qualify if:

• Patients meeting one or more of the below listed criteria will be excluded from the trial:
• History of colorectal cancer
• History of Inflammatory Bowel Disease
• Part of other control programme (e.g. HNPCC or adenoma control)
• ASA =/\> 4 and/or necessity of general anaesthesia
• Former surgery with removal of a part of the colon on either benign or malignant background

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital Køge, Department of Surgery

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Cryopyrin-Associated Periodic Syndromes

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Chronic Inducible Urticaria; Chronic Urticaria; Urticaria; Skin Diseases, Vascular; Cold Urticaria; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Line E Line, MD

  Zealand University Hospital Køge

  PRINCIPAL INVESTIGATOR

• Ismayil Gögenur, Prof, DMSc

  Zealand University Hospital Køge

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It is partially blinded in the way that the endoscopist knows whether the procedure is performed with or without the EndoRings but neither patient, pathologist nor investigators will have this information, which is only to be revealed to the investigators at the end of data processing.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a single-centre prospective randomised clinical trial. Patients are included if they meet the specified inclusion criteria and accept to take part in the study after proper oral and written information (see patient information below). Specimens i.e. removed adenomas and biopsies of suspected malignancies are analysed by pathologists according to standard procedure. The pathologist will not know the nature of specimen collection (colonoscopy with or without EndoRings). The specimens are not saved for any other study related activities.

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: July 18, 2017
• Study Start: June 19, 2017
• Primary Completion: June 7, 2018
• Study Completion: June 7, 2018
• Last Updated: April 11, 2019

Record last verified: 2019-04

Locations

DK (1)