HyGIeaCare Procedure for Chronic Constipation
Withdrawn before enrolling · Not applicable
Conditions studied: Constipation - Functional
In brief
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.
Key facts
- Study ID
- NCT03335969
- Run by
- HyGIeaCare, Inc.
- People needed
- 0
- Starts
- 2018-03-01
- Expected to finish
- 2019-03-01
- Last updated by the study team
- 2019-09-23
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Mayo Clinic — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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