Use of a Colon Irrigation Device as a Preparation for a Colon Visualization Procedure

Not Applicable

Completed

• Conditions: Screening Colonoscopy
• Interventions: Device: HyGIeaCare colon irrigation

• Registration Number: NCT03458390
• Lead Sponsor: HyGIeaCare, Inc.

Brief Summary

A prospective, single center, study to evaluate the effectiveness of the HyGIeaCare Prep when used in combination with the PillCam COLON; the hypothesis is that the HyGIeaCare Prep will be easier for the patients to tolerate, and the results will be as good as the existing oral preparation.

Detailed Description

Patients who agree to participate in the study will have their HyGIeaCare procedure and then will present to the PillCam COLON room, in the same suite for the PillCam COLON procedure.

The commercial preparations for the PillCam COLON procedure will be the same, except the HyGIeaCare procedure will replace the split polyethylene glycol-electrolyte solution preparation.

2-days prior:

* Normal diet

* 10 glasses of liquid

1-day prior:

* Clear liquid diet all day

* Dulcolax 2 tabs at 2pm and 2 tabs at 8pm

* Nothing by mouth after midnight

Day of Procedure:

* 6am- Dulcolax 2 tabs

* 8am- HyGIeaCare Procedure

* 9am- ingest PillCam Colon

* 10am- ingest Reglan

* At small bowel detection, drink 10oz SUPREP and 32oz water

* 3hrs later- drink 10oz SUPREP and 32oz water

* 2hrs later- insert suppository

* 2hrs later- light meal

Study Timeline

• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-08
• Status Verified: 2019-06
• Study Start: 2019-06-27
• Primary Completion: 2020-01-19
• Study Completion: 2020-01-19
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patient referred for the PillCam COLON procedure

Exclusion Criteria

HyGIeaCare:

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 treated long-term with narcotics.

3. Patient does not have any of the contraindications listed below:

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

PillCam COLON:

1. Subject has dysphagia or any swallowing disorder
2. Subject has congestive heart failure
3. Subject has Diabetes type I.
4. Subject has had prior abdominal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
5. Subject has a cardiac pacemaker or other implanted electro medical device.
6. Subject has any allergy or other known contraindication to the medications used in the study
7. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
8. Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.
9. Subject with gastrointestinal motility disorders
10. Subject has known delayed gastric emptying
11. Subject has any condition, which precludes compliance with study and/or device instructions.
12. 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.
13. Subject suffers from life threatening conditions
14. Subject currently participating in another clinical study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HyGIeaCare and PillCam COLON	HyGIeaCare colon irrigation	Patient will receive the HyGIeaCare colon irrigation prior to their PillCam COLON procedure

Primary Outcome Measures

Name	Time	Method
Effectiveness of colon irrigation	Immediately after colon irrigation, PillCam COLON will be administered. A video will be taken of the procedure which will be used to measure the effectiveness of the colon irrigation.	Effectiveness of the HyGIeaCare Prep will be measured using a 5-point scale to evaluate the visual quality of bowel cleanliness identified in the PillCam Colon video (Excellent, Good, Fair, Adequate, Poor).

Secondary Outcome Measures

Name	Time	Method
Evaluation of adverse events	To be evaluated the day of the procedure	The CTCAE tool will be used to evaluate outcomes
Evaluation of patient satisfaction	To be evaluated on the day of the procedure	A standardized questionnaire will be used to measure outcomes

Trial Locations

Locations (1)

HyGIeaCare Center; 🇺🇸 Austin, Texas, United States