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HyGIeaCare Procedure for Chronic Constipation

NCT03335969 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-09-23

No results posted yet for this study

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

Interventions

DEVICE

colon irrigation

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

Sponsors & Collaborators

  • Biostatistical Consulting, Inc.

    collaborator OTHER

  • HyGIeaCare, Inc.

    lead INDUSTRY

Principal Investigators

  • Sarah Umar, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-03-01
Completion
2019-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03335969 on ClinicalTrials.gov