No Condition, Healthy IndividualsNCT07287007
Evaluating the Hemodynamic Performance of the VenAir Sequential Compression System
A study testing VenAir and SCD700 in people with No Condition, Healthy Individuals and No Conditions, Aged 20-64, run by Wellell Inc. Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- No Condition, Healthy Individuals, No Conditions, Aged 20-64
- What is being tested?
- VenAir and SCD700
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Oct 2025to 5 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
- Aged 20-64 years
- Leg circumference within the size range of the SCD700 and VenAir garments
Who cannot join
- 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
Show all 10Show fewer
- Dermatitis, gangrene, or severe wounds
- Massive edema of legs
- Pregnancy
- Pulmonary edema
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Wellell Inc.
New Taipei City, 236044
Cheng Yung Chang, +8862-2268-5568 ext. 2804, dylan.chang@wellell.com
About this study
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:
- 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.
- 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.
Read more
Researchers will compare VenAir and the SCD700 to see if the hemodynamic performance of VenAir is as well as or not worse than the SCD700.
Participants will lie down and rest for approximately 30 minutes to stabilize their heart rate. The researcher will then use ultrasound to measure the participant's blood flow while they wear different leg garments (one at a time) and also when no garment is worn.
- Being tested
- VenAir, SCD700
- Keywords
- Intermittent pneumatic compression, Hemodynamics, Venous thromboembolism prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenAirDevice
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.
SCD700Device
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.
| Study group | Role | What they receive |
|---|---|---|
| VenAir | Experimental | The VenAir and its garments (thigh, calf, foot) will be tested in a randomized testing order. Receives: Device: VenAir |
| SCD700 | Active comparator | The SCD700 and its garments (thigh, calf, foot) will be tested in a randomized testing order. Receives: Device: SCD700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During and immediately after device application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start6 Oct 2025
- Primary completion5 Oct 2026 (estimated)
- Study completion5 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for No Condition, Healthy IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wellell Inc. Taiwan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cheng Yung Chang, Principal investigator, Wellell Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287007
- Sponsor's protocol ID
- EC1140707-F
- Status last verified
- Jan 2026
- First submitted
- 3 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 6731693Kamm 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.
PubMed 3791348Labropoulos 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.
PubMed 335401321. 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
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.
PubMed 11700495Kakkos 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.
PubMed 11054225Sadaghianloo 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.
PubMed 26993875Reitsma 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.
PubMed 22345594Anderson 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.
PubMed 31794602Pavon 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.
PubMed 26525487Virchow RLK. Die Verstopfung den Lungenarterie und ihre Folgen. Beitr Exper Path Physiol. 1846;2(1).
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Hemodynamic Performance of the VenAir Sequential Compression System
- ClinicalTrials.gov ID
- NCT07287007
- Acronym / sponsor ID
- EC1140707-F
- Keywords
- Intermittent pneumatic compression, Hemodynamics, Venous thromboembolism prophylaxis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Wellell Inc. TaiwanIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 5 Oct 2026 (estimated)
- Study completion
- 5 Oct 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Researchers will compare VenAir and the SCD700 to see if the hemodynamic performance of VenAir is as well as or not worse than the SCD700.
Participants will lie down and rest for approximately 30 minutes to stabilize their heart rate. The researcher will then use ultrasound to measure the participant's blood flow while they wear different leg garments (one at a time) and also when no garment is worn.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VenAir | Experimental | Device: VenAirThe VenAir and its garments (thigh, calf, foot) will be tested in a randomized testing order. |
| SCD700 | Active comparator | Device: SCD700The SCD700 and its garments (thigh, calf, foot) will be tested in a randomized testing order. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults
- Aged 20-64 years
- Leg circumference within the size range of the SCD700 and VenAir garments
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenAirVenAir 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. | Device | VenAir |
| SCD700SCD700 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. | Device | SCD700 |
Primary outcome
Peak Velocity of Blood Flow Increasement
Time frame: During and immediately after device application
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Background: PubMed 6731693Muhe 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.
- Background: PubMed 3791348Kamm 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.
- Background: PubMed 33540132Labropoulos 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.
- Background1. 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: PubMed 11700495Kakkos 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.
- Background: PubMed 11054225Kakkos 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.
- Background: PubMed 26993875Sadaghianloo 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.
- Background: PubMed 22345594Reitsma 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.
- Background: PubMed 31794602Anderson 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.
- Background: PubMed 26525487Pavon 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.
- BackgroundVirchow RLK. Die Verstopfung den Lungenarterie und ihre Folgen. Beitr Exper Path Physiol. 1846;2(1).
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cheng Yung Chang principal investigator
Wellell Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VenAir and SCD700 in people with No Condition, Healthy Individuals and No Conditions, Aged 20-64, run by Wellell Inc. Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheng Yung Chang (+886 2-2268-5568 ext. 2804, dylan.chang@wellell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Velocity of Blood Flow Increasement (time frame: During and immediately after device application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07287007, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.