Safety Evaluation of Bowel Cleansing Regimen for PillCam® COLON 2 Capsule Endoscopy

NCT ID: NCT01575093

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-06-30

Brief Summary

This study is designed to evaluate the safety of a preparation regimen for PillCam® Colon 2 Capsule Endoscopy.

Detailed Description

The preparation regimen used for the PillCam® Colon 2 procedure consists of several colon cleansing materials.

Different combinations of the above regimen were tested and evaluated for safety by monitoring of adverse events in multiple clinical studies, with more than 1000 subjects enrolled to date. No Serious Adverse Events related to the preparation were noted.

In this study, each subject will be required to undergo serum chemistry tests (blood tests) at several time points to evaluate the safety of the regimen.

No capsule ingestion is involved.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

The preparation regimen

Regimen includes administration of 4 Senna tablets 2 days before the procedure, 2-liters of PEG on the evening before the procedure, 2-liters of PEG on the morning of the procedure, 10mg Metoclopramide, two boosts (6-oz and 3-oz) of SUPREP oral sulfate solution and a 10mg Bisacodyl suppository

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Subject is between 50 - 75 years of age.

2. Subject is healthy without any known disease, or any current symptoms of any disease or other abnormal condition.

3. Subject received an explanation about the nature of the study and agrees to provide written informed consent.

4. Subject has normal serum chemistry tests at baseline.

Exclusion Criteria

1. Subject has any allergy or other known contraindication to the medications used in the study.

2. Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.

3. Subject has Type 1 or Type II Diabetes.

4. Subject has any condition which precludes compliance with study instructions.

5. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.

6. Subject suffers from life threatening conditions.

7. Concurrent participation in another clinical trial using any investigational drug or device.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

PANKAJ K. KASHYAP, M.D.

Role: PRINCIPAL_INVESTIGATOR

Pinnacle Research Group, LLC

Locations

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Countries

United States

Related Links

http://www.pinnacletrials.com/

Pinnacle Research Group website

Other Identifiers

MA-112

Identifier Type: -

Identifier Source: org_study_id