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NCT04335981
Determining Swallow Outcomes in Head & Neck Lymphedema Subjects Receiving Early Intervention With Pneumatic Compression
NA trial testing FT-CC and Swallow Exercises in Head and Neck Lymphedema in 22 participants. Terminated before completion.
1 October 2022
Quick facts
| Lead sponsor | Tactile Medical |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 24 September 2020 |
| Primary completion | 1 October 2022 |
| Estimated completion | 1 October 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- FT-CC and Swallow Exercises
- Swallow Exercises
Conditions studied
- Head and Neck Lymphedema — all drugs for Head and Neck Lymphedema →
Sponsor
Tactile Medical — full company profile →
Who can join
18 and older, any sex, with Head and Neck Lymphedema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of the study is to assess the effect early pneumatic compression (prior to confirming cancer-free status via PET or CT imaging) has on swallow outcomes, positron emission tomography (PET) measurements, function, and complication rate post-radiotherapy in subjects treated for oropharyngeal cancer.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04335981
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Tactile Medical trials
Trials by the same sponsor.
- NCT04797390 — A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema · NA · completed
- NCT04432727 — Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema. · NA · completed
- NCT04073823 — A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients · NA · terminated
- NCT04116099 — CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treatment of Lymphedema · terminated
- NCT03558672 — A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema · terminated
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 NCT04335981 (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 Tactile Medical
- Last refreshed: 17 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/NCT04335981.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing