HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy

Not Applicable

Withdrawn

• Conditions: Colonoscopy
• Interventions: Device: HyGIeaCare Prep; Procedure: Colonoscopy; Drug: polyethylene glycol (PEG)

• Registration Number: NCT02893748
• Lead Sponsor: HyGIeaCare, Inc.

Brief Summary

The purpose of this study is to compare the level of cleanliness using the HyGIeaCare Prep vs the standard of care Split-dose PEG prep used prior to colonoscopy.

Detailed Description

The level of cleanliness will be recorded using the Boston Bowel Prep Score (BBPS) by an endoscopist who is blind to the randomized preparation.

Study Timeline

• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-08
• Status Verified: 2018-02
• Study Start: 2019-03-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patient referred to colonoscopy

2. Patient with high probability for poor prep due to one or more of the following:

   1. Chronic constipation (Rome III functional constipation criteria)
   2. Gastroparesis
   3. Immobilization
   4. Diabetes
   5. History of poor prep

Exclusion Criteria

1. Patient has any condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study.

2. Patient is currently taking narcotics.

3. Patient has any of the contraindications listed below:

   1. Cardiac: Congestive heart failure (NYHA class III or IV or EF < 50%)
   2. GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery
   3. GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites
   4. Abdominal surgery within the last 6 months
   5. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: HyGIeaCare Prep and Colonoscopy	Colonoscopy	Patients will receive: 1. HyGIeaCare Prep 2. Colonoscopy
1: HyGIeaCare Prep and Colonoscopy	HyGIeaCare Prep	Patients will receive: 1. HyGIeaCare Prep 2. Colonoscopy
2: Split-dose PEG Prep and Colonoscopy	polyethylene glycol (PEG)	Patients will receive: 1. Split-dose PEG 2. Colonoscopy
2: Split-dose PEG Prep and Colonoscopy	Colonoscopy	Patients will receive: 1. Split-dose PEG 2. Colonoscopy

Primary Outcome Measures

Name	Time	Method
Colon cleanliness will be measured in both groups according to the Boston Bowel Preparation Scale (BBPS)	Day 1 of colonoscopy

Secondary Outcome Measures

Name	Time	Method
Evaluation of patient satisfaction using a Questionnaire	2 Days after colonoscopy	Questionnaire
Evaluation of adverse events	2 Days after colonoscopy	Questionnaire