Clinical trials: Negative Pressure Therapy
Obstructive Sleep Apnea
Pilot Study of Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea
This is a pilot study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.
- Trial name
- NCT02324790
- Testing
- iNAP® Sleep Therapy System
- Where
- 4 sites in Taiwan
- Volunteers
- 34 people
- Sponsor
- Somnics, Inc.
Soft Tissue Defects, Soft Tissue Wounds
Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
- Conditions
- Soft Tissue Defects, Soft Tissue Wounds, Traumatic Soft Tissue Defect
- Trial name
- COVER (NCT07385313)
- Testing
- Myriad™ applied in conjunction with NPWT, NPWT Alone
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Aroa Biosurgery Limited
Venous Leg Ulcer, Pressure Ulcer
Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in…
- Conditions
- Venous Leg Ulcer, Pressure Ulcer, Diabetic Foot Ulcer, Chronic Ulcer
- Trial name
- ASOLO-CW (NCT04753294)
- Testing
- Avance Solo NPWT System, Avance Solo Adapt NPWT System
- Where
- 13 sites in Belgium, Denmark and 5 more
- Volunteers
- 136 people
- Sponsor
- Molnlycke Health Care AB
Sleep Apnea, Obstructive
cNEP for the Treatment of Obstructive Sleep Apnea
The purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea
- Trial name
- cNEP (NCT02677168)
- Testing
- cNEP
- Where
- Canada
- Volunteers
- 71 people
- Sponsor
- Sommetrics, Inc.
Venous Leg Ulcer (VLU)
ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds
Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds.
- Trial name
- ConvaVAC VLU (NCT07342049)
- Testing
- ConvaVAC™ Ag+ Negative Pressure Wound Therapy System
- Where
- 7 sites in Chile, United Kingdom
- Volunteers
- 87 people
- Sponsor
- ConvaTec Inc.
Surgical Site Occurences After Sternotomy, Wound Infection
The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy).
- Trial name
- NCT02195310
- Testing
- Prevena™ Incision Management System, Conventional sterile wound dressings
- Where
- 13 sites in Austria, Germany and 1 more
- Volunteers
- 342 people
- Sponsor
- Solventum US LLC
Total Knee Arthroplasty, Total Hip Arthroplasty Revision
Interventional Study Exploring the Occurrence of Surgical Site Infections.
Interventional study exploring surgical site complication occurrences in high-risk revision patients undergoing TKA or THA using NPWT.
- Conditions
- Total Knee Arthroplasty, Total Hip Arthroplasty Revision, Total Knee Arthroplasty Revision
- Trial name
- NCT06661473
- Testing
- Avance Solo Negative Pressure Wound Therapy
- Where
- 8 sites in United States
- Volunteers
- 104 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer, Pressure Injury
A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System
The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
- Conditions
- Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer, Surgical Wound
- Trial name
- NCT04593693
- Testing
- Invia Motion Endure NPWT system
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Medela AG
Surgical Wound, Recent, Surgical Wound Leak
Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System
The main questions the study aims to answer are: How much do wounds improve when using the Avelle™ Negative Pressure Wound Therapy System for a maximum of 14 days? How safe is the Avelle™ Negative Pressure Wound Therapy System?
- Conditions
- Surgical Wound, Recent, Surgical Wound Leak, Dehiscence Wound, Trauma-related Wound
- Trial name
- NCT05805046
- Testing
- Negative Pressure Wound Therapy System
- Where
- 4 sites in United States
- Sponsor
- ConvaTec Inc.
Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)
INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
This prospective observational study will collect routine clinical waste material from 72 adults with chronic, non-healing wounds, including wound exudate from negative pressure therapy containers or sponges and wound…
- Trial name
- INJECTHEAL (NCT07745764)
- Testing
- standard of care
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Barbara Wolff-Winiski
Wounds
Comparative Effectiveness Study of MIST Therapy Versus Negative Pressure Wound Therapy
The purpose of this study is to evaluate the clinical and economic effectiveness of MIST Therapy vs NPWT vs MIST Therapy in conjunction with NPWT in the treatment of full thickness wounds presenting in the LTACH and SNF settings.
- Trial name
- NCT01200563
- Testing
- MIST Therapy, Vacuum Assisted Closure, MIST Therapy and Negative Pressure Wound Therapy
- Where
- United States
- Sponsor
- Celleration, Inc.
Multiple Sclerosis, Spasticity, Muscle
Pilot Investigation to Evaluate FlowOx2.0™ for Experimental Treatment of Spasticity
This is a descriptive, prospective, non-controlled clinical investigation to be conducted on approximately 10 enrolled subjects at one site at Haukeland University Hospital in Bergen, Norway.
- Conditions
- Multiple Sclerosis, Spasticity, Muscle, Pain
- Trial name
- FlowOx-MS (NCT04904016)
- Testing
- FlowOx™
- Where
- Norway
- Volunteers
- 10 people
- Sponsor
- Otivio AS
Pressure Ulcers
Efficacy of Quantum NPWT With Simultaneous Irrigation on Reduction of Wound Volume in Stage III/IV Pressure Ulcers.
Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and promotes granulation tissue and angiogenesis.
- Trial name
- NCT01734109
- Testing
- Quantum Negative Pressure Wound Therapy Device
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Innovative Therapies, Inc.
Wound, Wound Heal
Evaluation of V.A.C. VERAFLO CLEANSE CHOICE™ Dressing Using Normal Saline to Promote Increased Healthy Wound Bed Tissue
The study goal is to evaluate the ability of the V.A.C. ULTA™ Negative Pressure Wound Therapy System and V.A.C. VERAFLO CLEANSE CHOICE ™ (VFCC) dressing system with saline as an irrigant in increasing viable tissue in full…
- Conditions
- Wound, Wound Heal, Wounds and Injuries, Granulation Tissue
- Trial name
- NCT04026334
- Testing
- V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- 3M
Post-operative Complications, Surgical Site Infection
The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions
The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.
- Conditions
- Post-operative Complications, Surgical Site Infection, Surgical Wound Infection
- Trial name
- NCT01450631
- Testing
- Prevena™ Incision Management System (PIMS), Standard-of-care Dressing
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- KCI USA, Inc
Abdomenal Wound Trauma
Non-Comparative Study of Open Abdomen That Require the Use of Negative Pressure Wound Therapy (NPWT) for Temporary Abdominal Closure
A study in which subjects with a Grade 1 or Grade 2 open abdomen that require the use of NPWT for temporary abdominal closure. Subjects will use the NPWT system for up to 14 days, with a 21 day post study initiation follow-up…
- Trial name
- NCT03431220
- Testing
- RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device
- Where
- United States
- Sponsor
- Smith & Nephew, Inc.