NCT03335969

HyGIeaCare Procedure for Chronic Constipation

Evaluation of the HyGIeaCare Procedure for Patients With Chronic Constipation

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: HyGIeaCare, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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 who failed to improve with currently available therapy (osmotic and stimulant laxatives, used for at least one month at recommended dose). Once patients are consented to participate in the study, they will complete the Gastrointestinal Symptom Severity Index (GISSI) questionnaire. Patients will complete the 4 Week Bowel Movement Diary and 4 Week Medication Use Diary for the 4-weeks prior to their HyGIeaCare procedure. The Medication Use Diary will include any rescue medications taken above and beyond what patients are taking as part of their constipation regimen. The patient will schedule their HyGIeaCare procedure directly with the HyGIeaCare Clinic. The nurse manager can be reached at 480-750-2333. The clinic is located at 4001 E. Baseline Road, Gilbert, AZ. The nurse manager will provide the patient with any instructions needed prior to their HyGIeaCare procedure. HyGIeaCare will furnish the principle investigator with the complete patient care records after the irrigation procedure has been completed. Following the 4 weeks post the patient's HyGIeaCare procedure, the patient will complete a new 4 Week Bowel Movement Diary and 4 Week Medication Use Diary for the 4-weeks post their HyGIeaCare procedure. The patient will bring these documents to their clinic follow-up visit. At this visit the patient will complete another GISSI questionnaire and will be evaluated for possible adverse events. Patient data will be collected on hard copy case report forms (CRFs) and then entered into an electronic database.

Conditions

• Constipation - Functional

Interventions

Type	Name	Description
DEVICE	colon irrigation	Study is to compare bowel movement patterns before and after colon irrigation.

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2017-11-08
• Last updated: 2019-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study