PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon (MA-53)

Medtronic

Status and phase: Completed; Phase 3

Conditions: Colonic Diseases

Treatments: Device: PillCam COLON; Procedure: Standard colonoscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00604162

MA-53

Details and patient eligibility

About

To see if PillCam COLON will demonstrate diagnostic yield >80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.

Full description

The development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease.

This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting colon abnormalities. Note that the physician performing the capsule endoscopy and reading the capsule videos and the physician performing the colonoscopy were unaware of each other's findings until completion of the examinations and reports (assessor-blind).

Enrollment: 332 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject was referred for colonoscopy for one of the following reasons:

  • Subjects over ≥ 50 years of age with one or more of the following clinical symptoms: rectal bleeding, hematochezia, melena, positive Fecal Occoult Blood Test (FOBT), recent change of bowel habits, or diarrhea/constipation of recent onset.

  • Any subject ≥ 18 years of age with:

    • Positive findings in the colon on a GastroIntestinal (GI) radiographic study
    • Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 3 years since last colonoscopy
    • Suspected or known ulcerative colitis

Exclusion criteria

• Subject has dysphagia
• Subject has congestive heart failure
• Subject has renal insufficiency
• Subject is known or is suspected to suffer from intestinal obstruction.
• Chronic use of laxatives
• Subject has a cardiac pacemakers or other implanted electro medical devices.
• Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
• Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
• Subject has any condition, which precludes compliance with study and/or device instructions.
• Age < 18 years
• Subject suffers from life threatening conditions
• Subject is currently participating in another clinical study
• Subject has known slow gastric emptying time

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

332 participants in 1 patient group

PillCam COLON and Colonoscopy

Experimental group

Description:

Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases, had capsule endoscopy with PillCam COLON after bowel preparation and before standard colonoscopy.

Treatment:

Device: PillCam COLON

Procedure: Standard colonoscopy