HyGIeaCare Procedure for Chronic Constipation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the HyGIeaCare Procedure for Patients With Chronic Constipation

Conditions
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Constipation - Functional

Intervention / Treatment
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* Device: colon irrigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pre colon irrigation diaries followed by post diaries<br>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<br>* Study is to compare bowel movement patterns before and after colon irrigation.<br>* Other names: HyGIeaCare System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in constipation score and discomfort score (GISSI) | Gastrointestinal Symptom Severity Index (GISSI) constipation/difficult defecation cluster and abdominal pain/discomfort cluster | 8 weeks | 
| Change in rescue medications used | Review of the number of times rescue medications are used for constipation relief | 8 weeks |