Short Bowel SyndromeNCT06185088
MENDD Tolerance Assessment Study
A study testing Coda® Balloon Catheters and Double Balloon Endoscope (DBE) in people with Short Bowel Syndrome, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- Coda® Balloon Catheters and Double Balloon Endoscope (DBE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 6 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Existing Ileostomy older than 6 weeks Undergoing any existing procedure in endoscopy suite or operating room.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Michigan ENdoluminal Distraction Device (MENDD) Tolerance Assessment Study
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
- Being tested
- Coda® Balloon Catheters, Double Balloon Endoscope (DBE)
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coda® Balloon CathetersDevice
A balloon device that will be introduced into participants' intestine over a guide wire to test the radial stretch of the small bowel.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Coda® Balloon Catheters; Device: Double Balloon Endoscope (DBE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1-2 Minutes
Secondary outcomes (1)
Discomfort as Assessed by Visual Analog Scale for Longitudinal Stretch
Participant discomfort will be assessed using VAS during longitudinal stretch. The VAS is a scale ranging from 0 (no pain) to 10 (maximum pain).
Measured: Approximately 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start6 Mar 2023
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Why it stopped: Initial PI departed institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meghan A. Arnold, MD, University of Michigan
- Investigators
- Meghan A Arnold, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185088
- Sponsor's protocol ID
- HUM00208413
- Status last verified
- Sep 2024
- First submitted
- 14 Dec 2023
- Last updated
- 3 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Michigan ENdoluminal Distraction Device (MENDD) Tolerance Assessment Study
- ClinicalTrials.gov ID
- NCT06185088
- Acronym / sponsor ID
- HUM00208413
- Conditions
- Short Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Initial PI departed institution.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 29 Dec 2023 (actual)
- Results
- Posted 3 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Ostomies | Other | Device: Coda® Balloon Catheters, Device: Double Balloon Endoscope (DBE)Patients who have ostomies, and who are already undergoing a minor procedure for routine health screening or other health matters as standard of care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Existing Ileostomy older than 6 weeks Undergoing any existing procedure in endoscopy suite or operating room.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coda® Balloon CathetersA balloon device that will be introduced into participants' intestine over a guide wire to test the radial stretch of the small bowel. | Device | Participants with Ostomies |
| Double Balloon Endoscope (DBE)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. | Device | Participants with Ostomies |
Primary outcome
Discomfort as Assessed by Visual Analog Scale (VAS) for Radial Stretch
Time frame: 1-2 Minutes
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 secondary outcome
Discomfort as Assessed by Visual Analog Scale for Longitudinal Stretch
Time frame: Approximately 1 minute
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Short Bowel Syndrome
Active, not recruitingPhase 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Short Bowel Syndrome
Not yet recruitingPhase 2
Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
Enteric Hyperoxaluria
RecruitingPhase 3
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Short Bowel Syndrome
Active, not recruitingObservational study
Registry for Participants With Short Bowel Syndrome
Short Bowel Syndrome
Active, not recruitingPhase 3
A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
Short Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan A Arnold, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coda® Balloon Catheters and Double Balloon Endoscope (DBE) in people with Short Bowel Syndrome, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discomfort as Assessed by Visual Analog Scale (VAS) for Radial Stretch (time frame: 1-2 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.