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Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss
NA trial testing Transcutaneous Nerve Stimulator (TENS) in Overweight in 77 participants. Terminated before completion.
| Lead sponsor | Elira Therapeutics, Inc. |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 77 |
| Start date | 5 September 2017 |
| Primary completion | 1 April 2018 |
| Estimated completion | 1 April 2018 |
| Sites | 1 location across United States |
Elira Therapeutics, Inc.
Adults 18 to 65, any sex, with Overweight or Obesity. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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).
| Group | Value | 95% CI |
|---|---|---|
| Treatment | 0 | |
| Control | 0 |
Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment | Control |
|---|---|---|---|
| Contact dermatitis | Skin and subcutaneous tissue disorders | — | — |
| Gastroenteritis | Gastrointestinal disorders | — | — |
| Influenza | Respiratory, thoracic and mediastinal disorders | — | — |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Worsening contact dermatitis | Skin and subcutaneous tissue disorders | — | — |
| Flatulence | Gastrointestinal disorders | — | — |
| Urinary tract infection | Renal and urinary disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Blistering rash | Skin and subcutaneous tissue disorders | — | — |
| Body rash | Skin and subcutaneous tissue disorders | — | — |
| Vomitting | Gastrointestinal disorders | — | — |
| Intraductal papilloma mass, left breast | Reproductive system and breast disorders | — | — |
| Poison ivy | Skin and subcutaneous tissue disorders | — | — |
| Cracked tooth | General disorders | — | — |
| Torn rotator cuff | Musculoskeletal and connective tissue disorders | — | — |
| Elbow pain | Musculoskeletal and connective tissue disorders | — | — |
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | — | — |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Strep throat | Respiratory, thoracic and mediastinal disorders | — | — |
| Swelling, upper extremity | Musculoskeletal and connective tissue disorders | — | — |
| Bartholin's gland abscess | Reproductive system and breast disorders | — | — |
| Left knee pain | Musculoskeletal and connective tissue disorders | — | — |
| Venous thoracic outlet syndrome | Musculoskeletal and connective tissue disorders | — | — |
Data from ClinicalTrials.gov NCT03299881 adverse events section.
This study is a randomized, adaptive, parallel arm study. The treatment group will receive the Elira wearable patch system and provided instructions for use and advised to follow a 1200 calorie diet. The control group will be asked to follow a 12 calorie diet only. Each group will be followed for 12 weeks. Total body weight loss will be measured as well as appetite changes. Safety data will be collected throughout the study period. Safety and effectiveness will be determined based on differences between the groups.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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