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

NCT03458390 | Completed DMC FDA Device

• 1 other identifier: HGP-0005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Screening Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of adverse events

  To be evaluated the day of the procedure

• Evaluation of patient satisfaction

  To be evaluated on the day of the procedure

Study Arms (1)

HyGIeaCare and PillCam COLON

EXPERIMENTAL

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

Device: HyGIeaCare colon irrigation

Interventions

HyGIeaCare colon irrigation DEVICE

PillCam COLON for visualization of bowel lining

Also known as: PillCam COLON

HyGIeaCare and PillCam COLON

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient referred for the PillCam COLON procedure

You may not qualify if:

• HyGIeaCare:
• 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
• Patient is treated long-term with narcotics.
• Patient does not have any of the contraindications listed below:
• Cardiac: Congestive heart failure (NYHA class III or IV or Ejection Fraction \<50%)
• GastrointestinaI: Intestinal perforation, carcinoma of the rectum, Fissures or fistula, Severe hemorrhoids, Abdominal hernia, recent colon or rectal surgery, abdominal surgery
• Genitourinary: Renal insufficiency (CC \< 60 ml/min/173m2), cirrhosis with ascites
• Abdominal surgery within the last 6 months
• Pregnancy
• PillCam COLON:
• Subject has dysphagia or any swallowing disorder
• Subject has congestive heart failure
• Subject has Diabetes type I.
• 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
• Subject has a cardiac pacemaker or other implanted electro medical device.

Sponsors & Collaborators

• HyGIeaCare, Inc.: lead
• Medtronic: collaborator

Study Sites (1)

HyGIeaCare Center

Austin, Texas, 78757, United States

Location

Related Publications (2)

• 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.

  PMID: 25803399 BACKGROUND

• 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.

  PMID: 17625982 RESULT

Related 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
• HyGIeaCare® Preparation for Colonoscopy-A Technical Update for Success
• Multi-Dimensional Gastrointestinal Symptom Severity Index: Validation of a Brief GI Symptom Assessment Tool

Study Officials

• David A Johnson, MD

  Eastern Virginia Medical Center

  PRINCIPAL INVESTIGATOR

• William Stassen, MD

  Austin Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HyGIeaCare colon irrigation procedure and PillCam COLON procedure

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 8, 2018
• Study Start: June 27, 2019
• Primary Completion: January 19, 2020
• Study Completion: January 19, 2020
• Last Updated: July 31, 2020

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)