HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy

HyGIeaCare

Status: Withdrawn

Conditions: Colonoscopy

Treatments: Device: HyGIeaCare Prep; Drug: polyethylene glycol (PEG); Procedure: Colonoscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02893748

HGP-0004

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

1: HyGIeaCare Prep and Colonoscopy

Active Comparator group

Description:

Patients will receive: 1. HyGIeaCare Prep 2. Colonoscopy

Treatment:

Procedure: Colonoscopy

Device: HyGIeaCare Prep

2: Split-dose PEG Prep and Colonoscopy

Active Comparator group

Description:

Patients will receive: 1. Split-dose PEG 2. Colonoscopy

Treatment:

Procedure: Colonoscopy

Drug: polyethylene glycol (PEG)