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NCT05628298
Pulsed Heat as a Drug-free Treatment for Pregnancy Related Pain
trial testing Soovu Pain Relief System in Pain in 35 participants. Status unknown.
30 November 2023
Quick facts
| Lead sponsor | Soovu Labs Inc. |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 35 |
| Start date | 15 January 2023 |
| Primary completion | 30 November 2023 |
| Estimated completion | 30 March 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Soovu Pain Relief System
Conditions studied
- Pain — all drugs for Pain →
- Pain, Labor — all drugs for Pain, Labor →
Sponsor
Soovu Labs Inc. — full company profile →
Who can join
Adults 18 to 60, female only, with Pain or Pain, Labor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Studies indicate that up to 75% of women will experience pain sometime during their pregnancy. Recent recommendations by the FDA recommended that non-steroidal anti-inflammatory (NSAIDS) medications be avoided during pregnancy. This recommendation limits the pain medications available for use during pregnancy. Antidotal evidence suggests that the FDA cleared Soovu pulsed heat device may produce pain relief during pregnancy. This study tests the Soovu device's ability to provide pain relief during pregnancy and up to one month post-partum and may eventually offer a safe nondrug option to treat pregnancy related pain. This is an observational pilot study The primary objective and hypothesis of this study is that the use of the Soovu pain management device will produce a significant reduction of pain when comparing pre versus post treatment pain.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05628298
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Soovu Labs Inc. trials
Trials by the same sponsor.
- NCT06224127 — Treating Stress and Anxiety in Individuals With Alcohol Use Disorder (AUD) · Phase 1 · unknown
- NCT04407884 — Long Term Use of a High Energy Pulsed Heating Device in the Management of Chronic Pain · NA · unknown
- NCT04109703 — High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05628298 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Soovu Labs Inc.
- Last refreshed: 28 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05628298.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing