Trial Outcomes & Findings for Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss (NCT NCT03299881)
NCT ID: NCT03299881
Last Updated: 2021-11-10
Results Overview
Safety/Tolerability will be assessed by the non-inferiority of incidence of serious adverse events (SAEs), unanticipated DAEs (USAEs), device-related SAEs (DSAEs), and unanticipated device-related SAEs (UDAEs) that are associated with the TENS therapy throughout the stimulation and the follow-up period versus historical control (compared with other TENS systems).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
77 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-11-10
Participant Flow
Participant milestones
| Measure |
Treatment
The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.
Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.
Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
|
Control
Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.
Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
38
|
|
Overall Study
COMPLETED
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
17
|
13
|
Reasons for withdrawal
| Measure |
Treatment
The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.
Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.
Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
|
Control
Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.
Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
|
|---|---|---|
|
Overall Study
Study Termination
|
17
|
13
|
Baseline Characteristics
Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss
Baseline characteristics by cohort
| Measure |
Treatment
n=39 Participants
The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.
Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.
Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
|
Control
n=38 Participants
Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.
Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.2 years
n=5 Participants
|
46.5 years
n=7 Participants
|
47.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
38 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
BMI
|
29.9 kg/m^2
n=5 Participants
|
29.2 kg/m^2
n=7 Participants
|
29.6 kg/m^2
n=5 Participants
|
|
Weight
|
178.5 pounds
n=5 Participants
|
174.6 pounds
n=7 Participants
|
176.6 pounds
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Study was terminated and recruitment was stopped. Sincere efforts were made but technical difficulties with device prevented the necessary data collection to allow specified outcome analysis. Adverse event data is reported.
Safety/Tolerability will be assessed by the non-inferiority of incidence of serious adverse events (SAEs), unanticipated DAEs (USAEs), device-related SAEs (DSAEs), and unanticipated device-related SAEs (UDAEs) that are associated with the TENS therapy throughout the stimulation and the follow-up period versus historical control (compared with other TENS systems).
Outcome measures
| Measure |
Treatment
n=39 Participants
The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.
Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.
Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
|
Control
n=38 Participants
Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.
Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
|
|---|---|---|
|
Treatment Emergent Adverse Events
|
0 Serious Adverse Events
|
0 Serious Adverse Events
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=39 participants at risk
The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.
Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.
Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
|
Control
n=38 participants at risk
Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.
Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.1%
2/39 • Number of events 2 • 12 weeks
|
0.00%
0/38 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
23.1%
9/39 • Number of events 9 • 12 weeks
|
0.00%
0/38 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Blistering rash
|
2.6%
1/39 • Number of events 1 • 12 weeks
|
0.00%
0/38 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Worsening contact dermatitis
|
5.1%
2/39 • Number of events 2 • 12 weeks
|
0.00%
0/38 • 12 weeks
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
2/39 • Number of events 2 • 12 weeks
|
0.00%
0/38 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Body rash
|
2.6%
1/39 • Number of events 1 • 12 weeks
|
0.00%
0/38 • 12 weeks
|
|
Gastrointestinal disorders
Vomitting
|
2.6%
1/39 • Number of events 1 • 12 weeks
|
0.00%
0/38 • 12 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
15.4%
6/39 • Number of events 6 • 12 weeks
|
5.3%
2/38 • Number of events 2 • 12 weeks
|
|
Reproductive system and breast disorders
Intraductal papilloma mass, left breast
|
2.6%
1/39 • Number of events 1 • 12 weeks
|
0.00%
0/38 • 12 weeks
|
|
Renal and urinary disorders
Urinary tract infection
|
5.1%
2/39 • Number of events 2 • 12 weeks
|
2.6%
1/38 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Poison ivy
|
2.6%
1/39 • Number of events 1 • 12 weeks
|
0.00%
0/38 • 12 weeks
|
|
General disorders
Cracked tooth
|
2.6%
1/39 • Number of events 1 • 12 weeks
|
0.00%
0/38 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Torn rotator cuff
|
2.6%
1/39 • Number of events 1 • 12 weeks
|
0.00%
0/38 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
12.8%
5/39 • Number of events 5 • 12 weeks
|
5.3%
2/38 • Number of events 2 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
7.7%
3/39 • Number of events 3 • 12 weeks
|
13.2%
5/38 • Number of events 5 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Elbow pain
|
2.6%
1/39 • Number of events 1 • 12 weeks
|
0.00%
0/38 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/39 • 12 weeks
|
5.3%
2/38 • Number of events 2 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
0.00%
0/39 • 12 weeks
|
2.6%
1/38 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/39 • 12 weeks
|
5.3%
2/38 • Number of events 2 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/39 • 12 weeks
|
5.3%
2/38 • Number of events 2 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/39 • 12 weeks
|
2.6%
1/38 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Strep throat
|
0.00%
0/39 • 12 weeks
|
2.6%
1/38 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Swelling, upper extremity
|
0.00%
0/39 • 12 weeks
|
2.6%
1/38 • Number of events 1 • 12 weeks
|
|
Reproductive system and breast disorders
Bartholin's gland abscess
|
0.00%
0/39 • 12 weeks
|
2.6%
1/38 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Left knee pain
|
0.00%
0/39 • 12 weeks
|
2.6%
1/38 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Venous thoracic outlet syndrome
|
0.00%
0/39 • 12 weeks
|
2.6%
1/38 • Number of events 1 • 12 weeks
|
Additional Information
Stephanie Amlung, PhD, RN, Vice President, Clinical Affairs
Elira Therapeutics, Inc.
Phone: 513-236-6799
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place