Trial Outcomes & Findings for Omega Cuff for GERD Feasibility Study (NCT NCT04793035)
NCT ID: NCT04793035
Last Updated: 2026-09-02
Results Overview
Number of participants who experienced an adverse event
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
From enrollment to the end of study, up to 24 months
Results posted on
2026-09-02
Participant Flow
This early feasibility study was conducted from August 08, 2023, to February 13, 2026, involving participants with Gastroesophageal Reflux Disease, as defined by abnormal pH testing, who continue to have chronic GERD symptoms despite receiving maximum medical therapy for reflux. Participants were screened to assess their eligibility. Only individuals who met the inclusion and exclusion criteria were eligible to participate.
This was a single-arm study
Participant milestones
| Measure |
Intervention Group
Participants with an implantable single-use Omega PF
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Omega Cuff for GERD Feasibility Study
Baseline characteristics by cohort
| Measure |
Intervention Group
n=6 Participants
Participants with an implantable single-use Omega PF
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=136 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=136 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=136 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=136 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=136 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
|
Normalization of pH
|
0 Participants
n=136 Participants
|
PRIMARY outcome
Timeframe: From enrollment to the end of study, up to 24 monthsNumber of participants who experienced an adverse event
Outcome measures
| Measure |
Intervention Group
n=6 Participants
Participants with an implantable single-use Omega PF
|
|---|---|
|
Adverse Events
Bloating
|
2 Participants
|
|
Adverse Events
Chest discomfort
|
1 Participants
|
|
Adverse Events
Constipation
|
1 Participants
|
|
Adverse Events
Diarrhea
|
2 Participants
|
|
Adverse Events
Dysphagia
|
5 Participants
|
|
Adverse Events
Early Satiety
|
1 Participants
|
|
Adverse Events
Hypertension
|
1 Participants
|
|
Adverse Events
Overactive Bladder
|
1 Participants
|
|
Adverse Events
Rash
|
1 Participants
|
|
Adverse Events
Upper Respiratory Infection
|
1 Participants
|
|
Adverse Events
Urinary Stress Incontinence
|
1 Participants
|
|
Adverse Events
Vomiting
|
2 Participants
|
PRIMARY outcome
Timeframe: 3 and 12 months post-implantNumber of participants with normalization of pH (defined as pH \<4 for no more than 4.5% of monitoring time) or a reduction of at least 50% in the total time that pH \<4, at 3 and 12 months relative to baseline.
Outcome measures
| Measure |
Intervention Group
n=6 Participants
Participants with an implantable single-use Omega PF
|
|---|---|
|
Normalization of pH
3 months
|
3 Participants
|
|
Normalization of pH
12 months
|
4 Participants
|
PRIMARY outcome
Timeframe: 12 months post-implantNumber of participants with at least a 50% improvement in the GERD-HRQL scores at 12 months.
Outcome measures
| Measure |
Intervention Group
n=6 Participants
Participants with an implantable single-use Omega PF
|
|---|---|
|
GERD Health-Related Quality of Life Scale
|
6 Participants
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=6 participants at risk
Subjects seeking surgical intervention for GERD who meet the study inclusion/exclusion criteria are eligible for this study. The 6 study subjects were implanted with the device.
|
|---|---|
|
Gastrointestinal disorders
Dysphagia
|
83.3%
5/6 • From enrollment until the end of follow-up, up to 24 months
Subjects were queried at each follow-up visit, and all adverse events were documented.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • From enrollment until the end of follow-up, up to 24 months
Subjects were queried at each follow-up visit, and all adverse events were documented.
|
|
Cardiac disorders
Hypertension
|
16.7%
1/6 • From enrollment until the end of follow-up, up to 24 months
Subjects were queried at each follow-up visit, and all adverse events were documented.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • From enrollment until the end of follow-up, up to 24 months
Subjects were queried at each follow-up visit, and all adverse events were documented.
|
|
Renal and urinary disorders
Urinary Stress Incontinence
|
16.7%
1/6 • From enrollment until the end of follow-up, up to 24 months
Subjects were queried at each follow-up visit, and all adverse events were documented.
|
|
Renal and urinary disorders
Overactive Bladder
|
16.7%
1/6 • From enrollment until the end of follow-up, up to 24 months
Subjects were queried at each follow-up visit, and all adverse events were documented.
|
|
Gastrointestinal disorders
Bloating
|
33.3%
2/6 • From enrollment until the end of follow-up, up to 24 months
Subjects were queried at each follow-up visit, and all adverse events were documented.
|
|
Cardiac disorders
Chest Discomfort
|
16.7%
1/6 • From enrollment until the end of follow-up, up to 24 months
Subjects were queried at each follow-up visit, and all adverse events were documented.
|
|
Gastrointestinal disorders
"Metal Taste" in Mouth
|
16.7%
1/6 • From enrollment until the end of follow-up, up to 24 months
Subjects were queried at each follow-up visit, and all adverse events were documented.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • From enrollment until the end of follow-up, up to 24 months
Subjects were queried at each follow-up visit, and all adverse events were documented.
|
|
Gastrointestinal disorders
Early Satiety
|
16.7%
1/6 • From enrollment until the end of follow-up, up to 24 months
Subjects were queried at each follow-up visit, and all adverse events were documented.
|
|
Skin and subcutaneous tissue disorders
Rash & Itching on Abdomen
|
16.7%
1/6 • From enrollment until the end of follow-up, up to 24 months
Subjects were queried at each follow-up visit, and all adverse events were documented.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
16.7%
1/6 • From enrollment until the end of follow-up, up to 24 months
Subjects were queried at each follow-up visit, and all adverse events were documented.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place