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

Screening Colonoscopy Clinical Trial

Official title:

Colon Irrigation Using HyGIeaCare as Prep for PillCam COLON Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458390
• Other study ID #: HGP-0005
• Status: Completed
• Phase: N/A
• Start date: June 27, 2019
• Est. completion date: January 19, 2020

Study information

• Verified date: June 2019
• Source: HyGIeaCare, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 19, 2020
• Est. primary completion date: January 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Screening Colonoscopy

Intervention

Device:
• HyGIeaCare colon irrigation
PillCam COLON for visualization of bowel lining

Locations

Country	Name	City	State
United States	HyGIeaCare Center	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
HyGIeaCare, Inc.	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2007 Jul 10. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of adverse events	The CTCAE tool will be used to evaluate outcomes	To be evaluated the day of the procedure
Secondary	Evaluation of patient satisfaction	A standardized questionnaire will be used to measure outcomes	To be evaluated on the day of the procedure

External 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
•   Multi-Dimensional Gastrointestinal Symptom Severity Index: Validation of a Brief GI Symptom Assessment Tool