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

Phase 1

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT01575093
• Lead Sponsor: Medtronic - MITG

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-11
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-11
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of a bowel preparation regimen comprised of Sulfate free Polyethylene glycol electrolyte lavage solution (SF-PEG) plus SUPREP oral sulfate solution as a "booster", in adult subjects.	Latest blood test conducted (i.e. 24 hours after suppository or seven days after procedure)	Safety will be evaluated by number of Adverse Events and percentage of subjects with clinically siginifcant change in serum chemistry test.

Trial Locations

Locations (1)

Pinnacle Research Group, LLC; 🇺🇸 Anniston, Alabama, United States