Evaluating the Hemodynamic Performance of the VenAir Sequential Compression System

NCT07287007 | Recruiting

• 1 other identifier: EC1140707-F
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn an Intermittent Pneumatic Compression Device (IPCD), VenAir, effectiveness in healthy adults. The main questions this research aims to answer are:

1. 1.The hemodynamic performance of VenAir paired with the thigh garments, calf garments, and foot garments is not inferior to that of SCD700 paired with the corresponding garments.
2. 2.The hemodynamic performance of VenAir paired with the thigh garments, calf garments, and foot garments is not inferior to that of SCD700 paired with the thigh garment.

Conditions

No Condition, Healthy Individuals; No Conditions, Aged 20-64

Keywords

Intermittent pneumatic compression; Hemodynamics; Venous thromboembolism prophylaxis

Outcome Measures

Primary Outcomes (1)

• Peak Velocity of Blood Flow Increasement

  The peak velocity increasement is measured to understand the degree of change in peak blood flow velocity with and without using the IPC device. Baseline peak velocity is calculated by averaging the two highest peaks over a 16-second period without the device. Intervention peak velocity is obtained by averaging the peak velocities over four compression cycles while wearing the IPC device.

  During and immediately after device application

Study Arms (2)

VenAir

EXPERIMENTAL

The VenAir and its garments (thigh, calf, foot) will be tested in a randomized testing order.

Device: VenAir

SCD700

ACTIVE COMPARATOR

The SCD700 and its garments (thigh, calf, foot) will be tested in a randomized testing order.

Device: SCD700

Interventions

VenAir DEVICE

VenAir is an intermittent pneumatic compression (IPC) device intended to help prevent venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). In this study, VenAir is applied to the participant's lower limb under standard operating settings, and hemodynamic performance is measured for comparison with SCD700.

VenAir

SCD700 DEVICE

SCD700 is a commercially available intermittent pneumatic compression (IPC) device used to prevent venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). In this study, SCD700 is applied to the participant's lower limb under standard operating settings, and hemodynamic performance is measured to compare with VenAir.

SCD700

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults
• Aged 20-64 years
• Leg circumference within the size range of the SCD700 and VenAir garments

You may not qualify if:

• Cardiovascular-related diseases (mild atherosclerosis, other ischemic vascular diseases, congestive heart failure, etc.)
• Previous suspicion of deep vein thrombosis, pulmonary embolism, or phlebitis
• History of stroke
• History of varicose vein surgery
• Hypertension
• Diabetes
• Dermatitis, gangrene, or severe wounds
• Massive edema of legs
• Pregnancy
• Pulmonary edema

Sponsors & Collaborators

• Wellell Inc. Taiwan: lead

Study Sites (1)

Wellell Inc.

New Taipei City, 236044, Taiwan

RECRUITING

Related Publications (11)

• Muhe E. Intermittent sequential high-pressure compression of the leg. A new method of preventing deep vein thrombosis. Am J Surg. 1984 Jun;147(6):781-5. doi: 10.1016/0002-9610(84)90200-9.

  PMID: 6731693 BACKGROUND

• Kamm R, Butcher R, Froelich J, Johnson M, Salzman E, Shapiro A, Strauss HW. Optimisation of indices of external pneumatic compression for prophylaxis against deep vein thrombosis: radionuclide gated imaging studies. Cardiovasc Res. 1986 Aug;20(8):588-96. doi: 10.1093/cvr/20.8.588.

  PMID: 3791348 BACKGROUND

• Labropoulos N, Giuliano KK, Tafur AJ, Caprini JA. Comparison of a nonpneumatic device to four currently available intermittent pneumatic compression devices on common femoral blood flow dynamics. J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1241-1247. doi: 10.1016/j.jvsv.2021.01.008. Epub 2021 Feb 1.

  PMID: 33540132 BACKGROUND

• 1. Virchow RLK. Die Verstopfung den Lungenarterie und ihre Folgen. Beitr Exper Path Physiol. 1846;2(1). 2. Pavon JM, Adam SS, Razouki ZA, et al. Effectiveness of Intermittent Pneumatic Compression Devices for Venous Thromboembolism Prophylaxis in High-Risk Surgical Patients: A Systematic Review. J Arthroplasty. 2016;31(2):524-532. doi:10.1016/j.arth.2015.09.043 3. Anderson DR, Morgano GP, Bennett C, et al. American Society of Hematology 2019 guidelines for management of venous thromboembolism: prevention of venous thromboembolism in surgical hospitalized patients. Blood Advances. 2019;3(23):3898-3944. doi:10.1182/bloodadvances.2019000975 4. Reitsma PH, Versteeg HH, Middeldorp S. Mechanistic View of Risk Factors for Venous Thromboembolism. ATVB. 2012;32(3):563-568. doi:10.1161/ATVBAHA.111.242818 5. Sadaghianloo N, Dardik A. The efficacy of intermittent pneumatic compression in the prevention of lower extremity deep venous thrombosis. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2016;4(2):248-256. doi:10.1016/j.jvsv.2015.07.006 6. Kakkos SK, Szendro G, Griffin M, Daskalopoulou SS, Nicolaides AN. The efficacy of the new SCD Response Compression System in the prevention of venous stasis. Journal of Vascular Surgery. 2000;32(5):932-940. doi:10.1067/mva.2000.110358 7. Kakkos SK, Szendro G, Griffin M, Sabetai MM, Nicolaides AN. Improved hemodynamic effectiveness and associated clinical correlations of a new intermittent pneumatic compression system in patients with chronic venous insufficiency. Journal of Vascular Surgery. 2001;34(5):915-922. doi:10.1067/mva.2001.118822 8. Morris RJ. Intermittent pneumatic compression - systems and applications. J Med Eng Technol. 2008;32(3):179-188. doi:10.1080/03091900601015147

  BACKGROUND

• Kakkos SK, Szendro G, Griffin M, Sabetai MM, Nicolaides AN. Improved hemodynamic effectiveness and associated clinical correlations of a new intermittent pneumatic compression system in patients with chronic venous insufficiency. J Vasc Surg. 2001 Nov;34(5):915-22. doi: 10.1067/mva.2001.118822.

  PMID: 11700495 BACKGROUND

• Kakkos SK, Szendro G, Griffin M, Daskalopoulou SS, Nicolaides AN. The efficacy of the new SCD response compression system in the prevention of venous stasis. J Vasc Surg. 2000 Nov;32(5):932-40. doi: 10.1067/mva.2000.110358.

  PMID: 11054225 BACKGROUND

• Sadaghianloo N, Dardik A. The efficacy of intermittent pneumatic compression in the prevention of lower extremity deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2016 Apr;4(2):248-56. doi: 10.1016/j.jvsv.2015.07.006. Epub 2015 Sep 15.

  PMID: 26993875 BACKGROUND

• Reitsma PH, Versteeg HH, Middeldorp S. Mechanistic view of risk factors for venous thromboembolism. Arterioscler Thromb Vasc Biol. 2012 Mar;32(3):563-8. doi: 10.1161/ATVBAHA.111.242818.

  PMID: 22345594 BACKGROUND

• Anderson DR, Morgano GP, Bennett C, Dentali F, Francis CW, Garcia DA, Kahn SR, Rahman M, Rajasekhar A, Rogers FB, Smythe MA, Tikkinen KAO, Yates AJ, Baldeh T, Balduzzi S, Brozek JL, Ikobaltzeta IE, Johal H, Neumann I, Wiercioch W, Yepes-Nunez JJ, Schunemann HJ, Dahm P. American Society of Hematology 2019 guidelines for management of venous thromboembolism: prevention of venous thromboembolism in surgical hospitalized patients. Blood Adv. 2019 Dec 10;3(23):3898-3944. doi: 10.1182/bloodadvances.2019000975.

  PMID: 31794602 BACKGROUND

• Pavon JM, Adam SS, Razouki ZA, McDuffie JR, Lachiewicz PF, Kosinski AS, Beadles CA, Ortel TL, Nagi A, Williams JW Jr. Effectiveness of Intermittent Pneumatic Compression Devices for Venous Thromboembolism Prophylaxis in High-Risk Surgical Patients: A Systematic Review. J Arthroplasty. 2016 Feb;31(2):524-32. doi: 10.1016/j.arth.2015.09.043. Epub 2015 Oct 29.

  PMID: 26525487 BACKGROUND

• Virchow RLK. Die Verstopfung den Lungenarterie und ihre Folgen. Beitr Exper Path Physiol. 1846;2(1).

  BACKGROUND

Study Officials

• Cheng Yung Chang

  Wellell Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng Yung Chang

CONTACT

+886 2-2268-5568; dylan.chang@wellell.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study uses a randomized crossover design in which each participant will be tested with two devices (VenAir and SCD700). The same participant will use both devices, allowing each participant to serve as their own control.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): October 5, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)