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NCT04680533 · ClinicalTrials.gov registry record · Phase 1
Wireless TENS for Peripheral Edema (Lower Limb Swelling)
A Phase 1 study, sponsored by University of Rochester.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT04680533: Clinical Trial Phase 1 study, sponsored by University of Rochester.
NCT04680533 is a Phase 1 study that was terminated before completion, run by University of Rochester. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04680533, a Phase 1 study, was terminated before completion, sponsored by University of Rochester.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study is single center, subject will receive a wireless TENS device. All subjects will be allowed to keep the commercially-available device for use after the study. The primary goal is to test the feasibility of the study design and secondary is to test the preliminary efficacy of the TENS.
Primary Outcome
Swelling and symptoms associated with edema will be recorded in the Edema Symptom Diary using a verbal rating scale of swelling in the lower limbs and feet using the anchors "none", "a little bit", "quite a bit" "a lot", or "very much", which converts to a 1 to 5 measurable scale, with \[1 = none, 5 = very much\]. The scores per each symptom per day will be summed and averaged over 7 days. The higher the score the worse the health outcome. The range of scores the participant can achieve per day
Interventions
- DEVICE Transcutaneous Electrical Nerve Stimulation (TENS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-06-28 |
| Est. Completion | 2024-02-22 |
| Phase | Phase 1 |
Why NCT04680533 stopped before completion
NCT04680533 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Transcutaneous Electrical Nerve Stimulation (TENS) is the first listed.
NCT04680533 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04680533 about?
NCT04680533 is a clinical study titled "Wireless TENS for Peripheral Edema (Lower Limb Swelling)". This study is single center, subject will receive a wireless TENS device. All subjects will be allowed to keep the commercially-available device for use after the study. The primary goal is to test the feasibility of the study design and secondary is to test the preliminary efficacy of the TENS.
What is the current status of trial NCT04680533?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2021-06-28. Estimated completion is 2024-02-22.
What interventions are being tested in trial NCT04680533?
The interventions under investigation include: Transcutaneous Electrical Nerve Stimulation (TENS) (DEVICE).
Who is sponsoring clinical trial NCT04680533?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04680533's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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