Trial Outcomes & Findings for MENDD Tolerance Assessment Study (NCT NCT06185088)
NCT ID: NCT06185088
Last Updated: 2024-10-03
Results Overview
Participant discomfort will be assessed using VAS during radial stretch. The VAS is a scale ranging from 0 (no pain) to 10 (maximum pain).
TERMINATED
NA
1 participants
1-2 Minutes
2024-10-03
Participant Flow
Participant milestones
| Measure |
Participants With Ostomies
Patients who have ostomies, and who are already undergoing a minor procedure for routine health screening or other health matters as standard of care.
Coda® Balloon Catheters: 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): 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.
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|---|---|
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MENDD Tolerance Assessment Study
Baseline characteristics by cohort
| Measure |
Participants With Ostomies
n=1 Participants
Patients who have ostomies, and who are already undergoing a minor procedure for routine health screening or other health matters as standard of care.
Coda® Balloon Catheters: 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): 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.
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|---|---|
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Age, Customized
18 years to 99 years
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1 Participants
n=99 Participants
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Sex: Female, Male
Female
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1 Participants
n=99 Participants
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Sex: Female, Male
Male
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0 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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0 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=99 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
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Race (NIH/OMB)
White
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0 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
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Region of Enrollment
United States
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1 participants
n=99 Participants
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PRIMARY outcome
Timeframe: 1-2 MinutesPopulation: Because only one participant was involved in the entire trial, showing data could violate privacy interests.
Participant discomfort will be assessed using VAS during radial stretch. The VAS is a scale ranging from 0 (no pain) to 10 (maximum pain).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 1 minutePopulation: Because only one participant was involved in the entire trial, showing data could violate privacy interests.
Participant discomfort will be assessed using VAS during longitudinal stretch. The VAS is a scale ranging from 0 (no pain) to 10 (maximum pain).
Outcome measures
Outcome data not reported
Adverse Events
Participants With Ostomies
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place