Trial Outcomes & Findings for Enterra Therapy Gastric Stimulation System (NCT NCT00556166)
NCT ID: NCT00556166
Last Updated: 2016-08-02
Results Overview
Data was not analyzed because PI left institution and terminated the study early.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
4 participants
Primary outcome timeframe
1 year
Results posted on
2016-08-02
Participant Flow
Participant milestones
| Measure |
Enterra Therapy
The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Enterra Therapy
The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Enterra Therapy Gastric Stimulation System
Baseline characteristics by cohort
| Measure |
Enterra Therapy
n=4 Participants
The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-specific gender count
|
4 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearData was not analyzed because PI left institution and terminated the study early.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearData was not analyzed because PI left institution and terminated the study early.
Outcome measures
Outcome data not reported
Adverse Events
Enterra Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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