Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Night Procedure

NCT00951587 | Completed Phase 3

• 1 other identifier: MA-104
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the effect of the night procedure in regards to colon cleansing level and capsule excretion rate.

Conditions

Colonic Diseases

Keywords

Colonic Diseases

Outcome Measures

Primary Outcomes (2)

• Colon cleansing level score

  within 7 days

• Transit time in the different GI regions until excretion

  within 7 days

Secondary Outcomes (3)

• Accuracy parameters of PCCE, compared to colonoscopy

  within 7 days

• Number of complete capsule procedure

  within 7 days

• Patient subjective assessment questionnaires

  within 7 days

Study Arms (1)

1

EXPERIMENTAL

Patients that are indicated for colonoscopy or who are suspected or known to suffer from colonic diseases.

Device: PillCam™ (Capsule Endoscopy)

Interventions

PillCam™ (Capsule Endoscopy) DEVICE

Medical Device

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is between the ages of 50-75 years and has an indication to undergo colonoscopy: At least 75% of total cases OR
• Subject is 18-50 suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy (e.g. rectal bleeding, melena, positive FOBT, recent change of bowel habits, CRC screening, UC, positive findings on a GI radiographic study - no more than 25% of total cases

You may not qualify if:

• Subject has dysphagia or any swallowing disorder
• Subject has severe Congestive heart failure (NYHA II or IV)
• Subject has renal insufficiency
• 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 judgement of the investigator
• Subject has a cardiac pacemaker or other implanted electromedical device.
• Subject has any allergy or other known contraindication to the medications used in the study
• Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, or NSAID enteropathy,
• Subject has any condition, which precludes compliance with study and/or device instructions.
• 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 suffers from life threatening conditions
• Subject currently participating in another clinical study

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (2)

Berufsgenossenschaftliche Universitätskliniken Bergmannsheil

Bochum, 44789, Germany

Location

Knappschaftskrankenhaus Medizinische Universitaetsklinik

Bochum, 44892, Germany

Location

MeSH Terms

Conditions

Colonic Diseases

Interventions

Capsule Endoscopy

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Wolff Schmiegel, Prof. Dr.

  Knappschaftskrankenhaus Medizinische Universitaetsklinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 2, 2009
• First Posted: August 4, 2009
• Study Start: February 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 31, 2019

Record last verified: 2010-03

Locations

DE (2)