MENDD Tolerance Assessment Study

NCT06185088 | Terminated Results FDA Device

• 1 other identifier: HUM00208413
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study will utilize approved devices in an off-label manner to create forces required to induce intestinal lengthening. Radial and longitudinal forces are both required, and two devices will be used to create forces in order to test tolerability of said forces. This is to provide evidence that humans could tolerate the forces produced by a proposed commercially built device. This study will test the hypothesis that radial and longitudinal forces necessary to produce enterogenesis will cause low levels of discomfort in healthy adults. Approved devices will be utilized in an off-label manner to reproduce forces similar to our novel medical device which is designed to treat short bowel syndrome (SBS). This trial will not be testing a treatment for SBS, and individuals with SBS are ineligible for recruitment.

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Discomfort as Assessed by Visual Analog Scale (VAS) for Radial Stretch

  Participant discomfort will be assessed using VAS during radial stretch. The VAS is a scale ranging from 0 (no pain) to 10 (maximum pain).

  1-2 Minutes

Secondary Outcomes (1)

• Discomfort as Assessed by Visual Analog Scale for Longitudinal Stretch

  Approximately 1 minute

Study Arms (1)

Participants with Ostomies

OTHER

Patients who have ostomies, and who are already undergoing a minor procedure for routine health screening or other health matters as standard of care.

Device: Coda® Balloon Catheters; Device: Double Balloon Endoscope (DBE)

Interventions

Coda® Balloon Catheters DEVICE

A balloon device that will be introduced into participants' intestine over a guide wire to test the radial stretch of the small bowel.

Participants with Ostomies

Double Balloon Endoscope (DBE) DEVICE

A balloon device that will be introduced retrograde through the ileostomy and the inter-balloon distance will be increased causing stretch on the intestine to test longitudinal stretch. The DBE will only be used if a participant tolerated the Coda® Balloon Catheter intervention.

Participants with Ostomies

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Existing Ileostomy older than 6 weeks Undergoing any existing procedure in endoscopy suite or operating room.

You may not qualify if:

• Inflammatory bowel disease of small bowel Pregnant Short bowel syndrome Bleeding disorder Chronic pain disorder Individuals taking chronic pain medications including prescriptions, cannabinoids or over the counter.
• Individuals taking pain medications at the time of the procedure Cognitive Impairment to the extent that the questionnaire cannot be completed

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Meghan Arnold
• Organization: University of Michigan

meghanar@med.umich.edu

734-936-8978

Study Officials

• Meghan A Arnold, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 29, 2023
• Study Start: March 6, 2023
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: October 3, 2024
• Results First Posted: October 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)