Status:
WITHDRAWN
HyGIeaCare Procedure for Chronic Constipation
Lead Sponsor:
HyGIeaCare, Inc.
Collaborating Sponsors:
Biostatistical Consulting, Inc.
Conditions:
Constipation - Functional
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
Detailed Description
This study has a single center, prospective, open label design. Patients will serve as their own control. The population will include patients with chronic constipation according to Rome III criteria...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03335969
Start Date
March 1 2018
End Date
March 1 2019
Last Update
September 23 2019
Active Locations (1)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259