HyGIeaCare Procedure for Chronic Constipation

NCT03335969 | Withdrawn DMC FDA Device

• 1 other identifier: HGP-0003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety and clinical effectiveness of using the FDA cleared HyGIeaCare System to relieve constipation in patients not responding to standard laxative treatment. Each patient will serve as their own control by comparing their bowel habits in a diary 4 weeks prior to colon irrigation to the bowel habits in their diary 4 weeks post colon irrigation.

Conditions

Constipation - Functional

Outcome Measures

Primary Outcomes (1)

• Change in number of BMs

  Change in the number of bowel movements per week from the baseline period (4 weeks) to the four weeks of the post-HyGIeaCare period.

  8 weeks

Secondary Outcomes (2)

• Change in constipation score and discomfort score (GISSI)

  8 weeks

• Change in rescue medications used

  8 weeks

Study Arms (1)

pre colon irrigation diaries followed by post diaries

EXPERIMENTAL

4 week bowel movement and rescue medication diaries will be compared to same diaries used 4 weeks after the colon irrigation procedure

Device: colon irrigation

Interventions

colon irrigation DEVICE

Study is to compare bowel movement patterns before and after colon irrigation.

Also known as: HyGIeaCare System

pre colon irrigation diaries followed by post diaries

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has chronic constipation according to Rome III criteria
• Patient has not experienced relief of symptoms following treatment with available therapies (osmotic and stimulant laxatives) for at least one month at recommended doses.

You may not qualify if:

• Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation)
• Patient has secondary constipation (colonic obstruction, medications, metabolic cause)
• Patient has any other 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 has any of the contraindications listed below:
• Cardiac: Congestive heart failure (NYHA class III or IV or EF \<50%)
• GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery
• GU: Renal insufficiency (CC \< 60 ml/min/173m2), cirrhosis with ascites
• Abdominal surgery within the last 6 months
• Pregnancy

Sponsors & Collaborators

• HyGIeaCare, Inc.: lead
• Biostatistical Consulting, Inc.: collaborator

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Related Publications (2)

• Crowell MD, Umar SB, Lacy BE, Jones MP, DiBaise JK, Talley NJ. Multi-Dimensional Gastrointestinal Symptom Severity Index: Validation of a Brief GI Symptom Assessment Tool. Dig Dis Sci. 2015 Aug;60(8):2270-9. doi: 10.1007/s10620-015-3647-3. Epub 2015 Apr 5.

  PMID: 25842355 BACKGROUND

• 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 RESULT

Related Links

• Randomized Trial Comparing High Volume Rectal Water Irrigation with Standard 4 L Split-Dose PEG Preparatoin before Colonoscopy
• Use of health care resources and cost of care for adults with constipation

Study Officials

• Sarah Umar, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each patient will serve as their own control by comparing their bowel habits in a diary 4 weeks prior to colon irrigation to the bowel habits in their diary 4 weeks post colon irrigation.

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 8, 2017
• Study Start: March 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-03

Locations

US (1)