Colonic Capsule Endoscopy (CCE) for Screening of Neoplasm's A Pilot Study

NCT02303756 | Completed DMC

• 1 other identifier: S-20140141
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim is to evaluate the efficiency of capsule endoscopy (CCE) in in the detection of neoplasms compared to conventional colonoscopy in persons participating in the Danish screening program for colorectal cancer with a positive fecal occult blood with the colonoscopy being the gold standard.

Conditions

Rectal Bleeding

Outcome Measures

Primary Outcomes (1)

• Identification of neoplasia

  Compared to colonoscopy

  One week after examination

Secondary Outcomes (1)

• Completion rate

  24 hours

Study Arms (1)

Pillcam® COLON Capsule

EXPERIMENTAL

Detection of neoplastic lesions in colon and rectum compared to colonoscopy

Device: Pillcam® COLON Capsule

Interventions

Pillcam® COLON Capsule DEVICE

colonoscopy

Pillcam® COLON Capsule

Eligibility Criteria

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

You may qualify if:

• Positive feaecal occult bleeding test at screening

You may not qualify if:

• Previous gastrointestinal surgery except for appendectomy
• Known inflammatory bowel disease including Chrohn's disease and ulcerative colitis
• An ostomy
• Symptoms on bowel obstruction (recurrent abdominal pain, constipation or vomiting within the last 3 months)
• Vomiting in connection with the bowel emptying procedure

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odesne University Hospital

Odense, 5000, Denmark

Location

Related Publications (3)

• Buijs MM, Kroijer R, Kobaek-Larsen M, Spada C, Fernandez-Urien I, Steele RJ, Baatrup G. Intra and inter-observer agreement on polyp detection in colon capsule endoscopy evaluations. United European Gastroenterol J. 2018 Dec;6(10):1563-1568. doi: 10.1177/2050640618798182. Epub 2018 Sep 11.

  PMID: 30574327 DERIVED

• Buijs MM, Kobaek-Larsen M, Kaalby L, Baatrup G. Can coffee or chewing gum decrease transit times in Colon capsule endoscopy? A randomized controlled trial. BMC Gastroenterol. 2018 Jun 25;18(1):95. doi: 10.1186/s12876-018-0824-9.

  PMID: 29940864 DERIVED

• Blanes-Vidal V, Nadimi ES, Buijs MM, Baatrup G. Capsule endoscopy vs. colonoscopy vs. histopathology in colorectal cancer screening: matched analyses of polyp size, morphology, and location estimates. Int J Colorectal Dis. 2018 Sep;33(9):1309-1312. doi: 10.1007/s00384-018-3064-0. Epub 2018 May 1.

  PMID: 29717351 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Niels Qvist, professor

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 1, 2014
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 7, 2018

Record last verified: 2018-06

Locations

DK (1)