8 completed, 7 terminated, 1 enrolling by invitation, 1 recruiting. 12 Not applicable, 2 Phase 1, 2 Phase 2, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 12 | Completed 7, Terminated 4, Withdrawn 1 |
| Phase 1 | 2 | Completed 1, Enrolling by invitation 1 |
| Phase 2 | 2 | Completed 1, Enrolling by invitation 1 |
| Early Phase 1 | 1 | Recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment Advanced pneumatic compression device (APCD), Advanced pneumatic compression device (APCD) with revised compression programming, Indocyanine Green (IC-Green) - Lower Extremity Lymphedema | Early Phase 1 | Recruiting | Tactile Medical | 5 | 2026-07-09 | 2026-08-11 |
| Evaluation of Lymphatic Response to Physiotherapy in Patients With Swelling Associated With Superficial Venous Disease Indocyanine Green near infrared fluorescence imaging, advanced pneumatic compression, Duplex ultrasound - Chronic Venous Disease | Phase 1 / Phase 2 | Enrolling by invitation | The University of Texas Health Science Center, Houston | 34 | 2025-09-01 | 2025-09-16 |
| A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema Advanced Pneumatic Compression Device (APCD), Usual Care - Lymphedema, Lymphedema of Face | Not applicable | Completed | Tactile Medical | 236 | 2021-09-23 | 2026-03-02 |
| Determining Swallow Outcomes in Head & Neck Lymphedema Subjects Receiving Early Intervention With Pneumatic Compression FT-CC and Swallow Exercises, Swallow Exercises - Head and Neck Lymphedema | Not applicable | Terminated | Tactile Medical | 22 | 2020-09-24 | 2022-11-17 |
| Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema. Flexitouch Plus with Cellular Connectivity (FT-CC) - Breast Cancer Lymphedema | Not applicable | Completed | Tactile Medical | 29 | 2020-08-13 | 2023-05-24 |
| Lymphedema Treatment in Head and Neck Cancer Patients Flexitouch Plus system - Head and Neck Cancer | Not applicable | Withdrawn | Endeavor Health | 2020-04-23 | 2020-08-13 | |
| Intermittent Pneumatic Compression in Women With Lipo-lymphedema (Lipedema With Swelling) Flexitouch Plus and Conservative Care, Conservative Care - Lipedema, Lipolymphedema | Not applicable | Completed | Thomas Wright, MD | 36 | 2020-01-31 | 2022-08-23 |
| A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients Flexitouch Plus, Flexitouch Plus FT with software modification - Breast Cancer Related Lymphedema | Not applicable | Terminated | Tactile Medical | 2 | 2020-01-23 | 2023-01-18 |
| CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treatment of Lymphedema Conservative care, Flexitouch Plus - Lymphedema | Terminated | Tactile Medical | 63 | 2019-10-10 | 2022-03-31 | |
| A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema Flexitouch system with Head and Neck Garments - Head and Neck Lymphedema | Terminated | Tactile Medical | 18 | 2018-09-14 | 2020-09-02 | |
| A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment Flexitouch head and neck lymphedema treatment system, Standard home lymphedema care - Head and Neck Neoplasms, Head and Neck Cancer | Not applicable | Completed | Tactile Medical | 49 | 2018-01-02 | 2020-08-06 |
| Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema Head and neck garments for pneumatic compression device, NIRFLI with ICG - Head and Neck Neoplasms, Head and Neck Lymphedema | Phase 1 / Phase 2 | Completed | Tactile Medical | 11 | 2016-10-01 | 2019-04-09 |
| VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging Dual Action Pneumatic Compression Device, Multi-Layer Bandaging - Venous Leg Ulcer | Not applicable | Terminated | Tactile Medical | 56 | 2016-02-01 | 2020-02-19 |
| Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device (PCD) Advanced Pneumatic Compression Device - Lymphedema | Terminated | Tactile Medical | 249 | 2015-12-01 | 2023-04-03 | |
| Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs) Dual Action Pneumatic Compression - Venous Leg Ulcer, Chronic Venous Insufficiency | Not applicable | Completed | Tactile Medical | 28 | 2014-12-01 | 2017-03-27 |
| Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device pneumatic compression - 1 hour per day, pneumatic compression - 2 hours per day, pneumatic compression - 4 hours per day - Lower Extremity Lymphoedema, Leg Lymphoedema | Not applicable | Completed | Tactile Medical | 21 | 2013-11-11 | 2021-07-20 |
| Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort Dual Action Pneumatic Compression Device, Standard Compression Garments - Chronic Venous Insufficiency | Not applicable | Completed | Tactile Medical | 81 | 2013-11-01 | 2016-12-15 |
| Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema Flexitouch System, Hydroven FPR - Lymphedema | Not applicable | Terminated | Tactile Medical | 238 | 2010-11-02 | 2020-11-06 |
Lymphedema (9) · Head and Neck Neoplasms (3) · Breast Cancer Lymphedema (2) · Neoplasms (2) · Varicose Ulcer (2) · Lipedema (1) · Neoplasm Metastasis (1) · Venous Insufficiency (1) · Wounds and Injuries (1)
Indocyanine Green (2) · Compression Bandages (1) · Drug Delivery Systems (1) · Manual Lymphatic Drainage (1) · Ultrasonography, Doppler, Duplex (1)
United States (17) · United Kingdom (2) · Australia (1)
William Marston, MD (2) · Barbara Murphy, MD (1) · Christine J Moffatt, RN PhD (1) · Fedor Lurie, MD, PhD (1) · John C Rasmussen, PhD (1) · John Rasmussen, PhD (1) · Margaret Sneddon, RGN (1) · Mihir Bhayani, MD (1) · Nicolas Ajkay, MD (1) · Peter J Franks, PhD (1) · Peter Pappas (1) · Sarah Pesek, MD (1) · Sheila Ridner, PhD, RN (1) · Sheila Ridner, RN, PhD (1) · Thomas Maldonado, MD (1)