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

Colon Irrigation Using HyGIeaCare as Prep for PillCam COLON Procedure

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.

Study Overview

• Status: Completed
• Conditions: Screening Colonoscopy
• Intervention / Treatment: Device: HyGIeaCare colon irrigation

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78757
      • HyGIeaCare Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HyGIeaCare and PillCam COLON; Patient will receive the HyGIeaCare colon irrigation prior to their PillCam COLON procedure	Device: HyGIeaCare colon irrigation; PillCam COLON for visualization of bowel lining; Other Names: PillCam COLON

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of 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).	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.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HyGIeaCare, Inc.
• Collaborators: Medtronic
• Investigators: Principal Investigator: David A Johnson, MD, Eastern Virginia Medical Center; Principal Investigator: William Stassen, MD, Austin Gastroenterology

Publications and helpful links

General Publications

• Sommers T, Corban C, Sengupta N, Jones M, Cheng V, Bollom A, Nurko S, Kelley J, Lembo A. Emergency department burden of constipation in the United States from 2006 to 2011. Am J Gastroenterol. 2015 Apr;110(4):572-9. doi: 10.1038/ajg.2015.64. Epub 2015 Mar 24.
• Singh G, Lingala V, Wang H, Vadhavkar S, Kahler KH, Mithal A, Triadafilopoulos G. Use of health care resources and cost of care for adults with constipation. Clin Gastroenterol Hepatol. 2007 Sep;5(9):1053-8. doi: 10.1016/j.cgh.2007.04.019. Epub 2007 Jul 10.

Helpful Links

• Hydrotherapy compared with polyethylene glycol-electrolyte solution lavage and aqueous sodium phosphate as bowel preparation for elective colonoscopy: A prospective, randomized, single blinded trial
• Randomized trial comparing high volume rectal water irrigation with standard 4 liter split-dose polyethlene glycol-electrolyte solution preparation before colonoscopy
• Multi-Dimensional Gastrointestinal Symptom Severity Index: Validation of a Brief GI Symptom Assessment Tool

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2019
• Primary Completion (Actual): January 19, 2020
• Study Completion (Actual): January 19, 2020

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HGP-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Research outcomes will be evaluated by external statistician.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No