Trial Outcomes & Findings for Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy (NCT NCT04978090)
NCT ID: NCT04978090
Last Updated: 2023-10-10
Results Overview
Participants will be asked to rate their pain on a scale of 1-10, where 10 indicates more pain.
COMPLETED
NA
2 participants
Daily from admission to discharge, up to 1 year
2023-10-10
Participant Flow
Participant milestones
| Measure |
Enteroatmospheric Fistula (EAF) Management Solution
Participants will receive a custom fitted device designed to isolate EAF effluent independent of negative pressure wound therapy (NPWT) utilizing 3D printing technology to design a participant-matched device that more easily and effectively separates the participant's fistula and any emanated intestinal contents surrounding the wound.
3D printed EAF management device: Participants will receive a customized 3D printed device based on the EAF's output, size, shape, location, depth, and the participant's wound bed.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Enteroatmospheric Fistula (EAF) Management Solution
Participants will receive a custom fitted device designed to isolate EAF effluent independent of negative pressure wound therapy (NPWT) utilizing 3D printing technology to design a participant-matched device that more easily and effectively separates the participant's fistula and any emanated intestinal contents surrounding the wound.
3D printed EAF management device: Participants will receive a customized 3D printed device based on the EAF's output, size, shape, location, depth, and the participant's wound bed.
|
|---|---|
|
Overall Study
unable to adequately fit device
|
2
|
Baseline Characteristics
Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy
Baseline characteristics by cohort
| Measure |
Enteroatmospheric Fistula (EAF) Management Solution
n=2 Participants
Participants will receive a custom fitted device designed to isolate EAF effluent independent of negative pressure wound therapy (NPWT) utilizing 3D printing technology to design a participant-matched device that more easily and effectively separates the participant's fistula and any emanated intestinal contents surrounding the wound.
3D printed EAF management device: Participants will receive a customized 3D printed device based on the EAF's output, size, shape, location, depth, and the participant's wound bed.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Daily from admission to discharge, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Participants will be asked to rate their pain on a scale of 1-10, where 10 indicates more pain.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weekly from discharge until fistula resolves or study ends, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Participants will be asked to rate their pain on a scale of 1-10, where 10 indicates more pain.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Daily from admission to discharge, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Mobility will be assessed by asking the participant to select the following statement that most accurately describes their mobility: a. completely immobile; b. unable to sit up supported for less than 10 minutes; c. able to sit supported for more than 10 minutes; d. able to sit unsupported, can lift arms; e. can stand up and pivot torso; or f. can walk and move with minimal assistance required.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weekly from until fistula resolves or study ends, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Mobility will be assessed by asking the participant to select the following statement that most accurately describes their mobility: a. completely immobile; b. unable to sit up supported for less than 10 minutes; c. able to sit supported for more than 10 minutes; d. able to sit unsupported, can lift arms; e. can stand up and pivot torso; or f. Can walk and move with minimal assistance required.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Daily from admission to discharge, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
The number of dressing changes will be tracked for inpatients on a daily bases.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Daily from discharge until fistula resolves or study ends, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
The number of dressing changes will be tracked for outpatients on a daily bases.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Daily from admission to discharge, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Inpatient participants will be asked three questions about the perceived usefulness of the device. The questions use a 5-point Likert scale ranging from strongly disagree to strongly agree, where strongly agree indicates a higher perceived usefulness.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weekly from discharge until fistula resolves or study ends, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Outpatient participants will be asked two questions about the perceived usefulness of the device. The questions use a 5-point Likert scale ranging from strongly disagree to strongly agree, where strongly agree indicates a higher perceived usefulness.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Daily from admission to discharge, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Inpatient participants will be asked four questions about the perceived ease of use of the device. The question uses a 5 point Likert scale ranging from strongly disagree to strongly agree, where strongly agree indicates a higher perceived ease of use.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weekly from discharge until fistula resolves or study ends, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Inpatient participants will be asked four questions about the perceived ease of use of the device. The question uses a 5 point Likert scale ranging from strongly disagree to strongly agree, where strongly agree indicates a higher perceived ease of use.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Daily from admission to discharge, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
The time required to change the wound dressings will be recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through duration of study, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
The number of infections in participants that are related to the device will be recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through duration of study, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
The number of observed leakages in participants that are related to the device will be recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through duration of study, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Length of stay in hospital
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through duration of study, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Fistula resolution time for participants
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through duration of study, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
The number of complication occurrences related to the device will be recorded.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Weekly from beginning of study until the end of the study, up to 1 yearPopulation: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
The cost of the patient management with the device will be estimated
Outcome measures
Outcome data not reported
Adverse Events
Enteroatmospheric Fistula (EAF) Management Solution
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