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

NCT ID: NCT03458390

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-27
• Study Completion Date: 2020-01-19

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

Conditions

Screening Colonoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

HyGIeaCare and PillCam COLON

Patient will receive the HyGIeaCare colon irrigation prior to their PillCam COLON procedure

Group Type: EXPERIMENTAL

HyGIeaCare colon irrigation

Intervention Type: DEVICE

PillCam COLON for visualization of bowel lining

Interventions

HyGIeaCare colon irrigation

PillCam COLON for visualization of bowel lining

Intervention Type: DEVICE

Other Intervention Names

PillCam COLON

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

HyGIeaCare, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David A Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical Center

William Stassen, MD

Role: PRINCIPAL_INVESTIGATOR

Austin Gastroenterology

Locations

HyGIeaCare Center

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25803399 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17625982 (View on PubMed)

Related Links

http://www.alliedacademies.org/articles/randomized-trial-comparing-high-volume-rectal-water-irrigation-with-standard-4-l-splitdose-peg-preparation-before-colonoscopy.pdf

Randomized trial comparing high volume rectal water irrigation with standard 4 liter split-dose polyethlene glycol-electrolyte solution preparation before colonoscopy

http://www.hygieacare.com/assets/2016_gagneja_hygieacare-preparation-for-colonscopy---a-technical-update-for-success.pdf

HyGIeaCare® Preparation for Colonoscopy-A Technical Update for Success

https://link.springer.com/article/10.1007%2Fs10620-015-3647-3

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

Other Identifiers

HGP-0005

Identifier Type: -

Identifier Source: org_study_id