HygiRelief Procedure and HygiSample Evaluation for Functional Constipation

NCT04532879 | Withdrawn FDA Device

• 1 other identifier: HGP-0009
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study has a single center, prospective, open label design. The population will include patients diagnosed with Rome IV Functional Constipation who are at the time of study enrollment being managed with a stable dose of Linzess. They will stop taking their Linzess, undergo monitoring of bowel habits for 2 weeks, have a HygiRelief procedure and then undergo an additional 2 weeks of bowel habit monitoring.

Conditions

Rome IV Functional Constipation

Outcome Measures

Primary Outcomes (1)

• Assess change in bowel movements PRE and POST HygiRelief procedure

  Evaluate the clinical effectiveness of the HygiRelief procedure to relieve functional constipation in patients previously managed with a stable dose of Lizess

  12 months

Secondary Outcomes (1)

• Assess colon effluent samples (HygiSample) collected during the HygiRelief procedure

  12 months

Study Arms (1)

All patients enrolled

EXPERIMENTAL

Bowel habits before and after the HygiRelief procedure will be assessed. Samples will be sent for microbiome evaluation.

Device: HygiPrep (HyGIeaCare System)

Interventions

HygiPrep (HyGIeaCare System) DEVICE

Controlled gravity-based high-volume colon irrigation

Also known as: HygiSample (stool collection for microbiome evaluation)

All patients enrolled

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's age is between 18 and 80 years old
• Patient diagnosed with Rome IV Functional Constipation (Attachment C2)
• Patient is currently managed with Linzess and willing to stop taking it for study duration

You may not qualify if:

• Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation)
• 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, rectal, or abdominal surgery
• GU: Renal insufficiency (CC \< 60 ml/min/173m2), cirrhosis with ascites
• Abdominal surgery within the last 6 months
• Pregnancy
• Patient took antibiotics within two months of starting the study

Sponsors & Collaborators

• HyGIeaCare, Inc.: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single center, open label. Patients will serve as their own control by comparing their bowel habits using a specific diary 2 weeks after the Linzess washout period to the 2 weeks after their HygiRelief procedure.

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 31, 2020
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share