Clinical trials: Surgical Performance
Rheumatoid Arthritis, Osteoarthritis
A Multi-centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery
The purpose of this study is to monitor the performance and determine the metal ion release of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders
- Trial name
- NCT00208377
- Testing
- DePuy ASR Hip System
- Where
- 3 sites in Australia, Germany and 1 more
- Volunteers
- 228 people
- Sponsor
- DePuy International
Chronic Low-back Pain, Herniated Disc
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV…
- Conditions
- Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease, Lumbar Canal Stenosis
- Trial name
- LISA-PMCF (NCT04631133)
- Testing
- Lumbar Implant for Stiffness Augmentation (LISA)
- Where
- 5 sites in Denmark, France and 1 more
- Volunteers
- 136 people
- Sponsor
- BACKBONE
Mitral Valve or Aortic Valve Replacement
Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese Patients
To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or 2800TFX) from three hospitals in China. To track the patients'situations during one year after surgery and to collect the relevant clinical…
- Trial name
- NCT02400489
- Where
- 3 sites in China
- Volunteers
- 265 people
- Sponsor
- Edwards Lifesciences
Critical Illness
Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit
Hyperglycaemia is commonly found in critically ill patients. Clinical studies demonstrated that tight blood glucose control in medical and surgical ICU patients results in a significant better outcome for the patients.
- Trial name
- Aldea_02 (NCT00882427)
- Testing
- enhanced model predictive control algorithm (eMPC)
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- B. Braun Melsungen AG
Cataract Surgery
The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance
Prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes.
- Trial name
- NCT04146961
- Testing
- Alcon PanOptix or PanOptix Toric IOL
- Where
- 3 sites in United States
- Volunteers
- 59 people
- Sponsor
- Research Insight LLC
Peripheral Arterial Disease
Advanta VXT and Flixene PMCF Registry
The purpose of the registry is to evaluate the long-term safety and performance of Advanta VXT and Flixene vascular grafts for repair or replacement of peripheral arteries.
- Trial name
- NCT07161583
- Testing
- Advanta VXT Vascular Graft, Flixene Vascular Graft
- Where
- 2 sites in United States, France
- Volunteers
- 1,000 people
- Sponsor
- Atrium Medical Corporation
Inguinal Hernia
Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair
The goal of this retrospective study is to identify the incidence of hernia recurrence following the application of Histoacryl® Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery.
- Trial name
- HISTOLAP (NCT06298500)
- Testing
- hernia repair surgery
- Where
- Spain
- Volunteers
- 443 people
- Sponsor
- Aesculap AG
Gall Bladder Disease, Bile Duct Diseases
AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study
This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips.
- Conditions
- Gall Bladder Disease, Bile Duct Diseases, Acute Cholecystitis, Kidney
- Trial name
- AE05ML (NCT06364865)
- Testing
- laparoscopic procedure
- Where
- 3 sites in United States
- Volunteers
- 161 people
- Sponsor
- Teleflex
Aphakia, Corneal Astigmatism
Evaluation of the Safety and Performance of the HARMONI® Toric Lens
The purpose of this study was to evaluate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic (HMTIOL) in subjects with pre-existing corneal astigmatism in need of cataract surgery.
- Conditions
- Aphakia, Corneal Astigmatism, Cataract
- Trial name
- NCT03050697
- Testing
- HARMONI® Modular Toric Intraocular Lens, Cataract extraction with intraocular lens (IOL) implantation
- Where
- New Zealand
- Volunteers
- 16 people
- Sponsor
- ClarVista Medical
Hearing Loss
Ponto Implantation Using a Minimally Invasive Surgical Technique
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands).
- Trial name
- NCT04606823
- Testing
- Minimally invasive surgery, Glasgow Benefit Inventory (GBI), Additional follow-up visits after surgery
- Where
- 7 sites in Denmark, Netherlands and 2 more
- Volunteers
- 52 people
- Sponsor
- Oticon Medical
Thrombus, Embolus
A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters
A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter
- Conditions
- Thrombus, Embolus, Occlusion; Vessel
- Trial name
- OTW (NCT05386342)
- Testing
- TufTex Over-the-Wire Embolectomy Catheter
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 112 people
- Sponsor
- LeMaitre Vascular
Breast Implant Revision, Congenital Breast Defect Correction
Scaffold-guided Breast Surgery
The clinical trial is testing the use of a novel method to grow new tissue within the breast injecting fat tissue harvested from patient's own fat deposits.
- Trial name
- NCT05437757
- Testing
- Surgical implantation of the PCL Breast scaffold with autologous fat grafting
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
Sepsis, SIRS
The Ward Study for SeptiCyte® Lab to Distinguish Between Infection-positive and Infection-negative SIRS
A non-interventional, prospective observational study to assess the performance of SeptiCyte® Lab to diagnose patients identified as suspected of sepsis in general medical and surgical wards with infection-positive from…
- Trial name
- NCT02704871
- Testing
- SeptiCyte Lab molecular diagnostic test (non-interventional)
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Immunexpress
Diabetic Ulcers, Venous Leg Ulcer
PMCF Study of Debridement Pad
The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by…
- Conditions
- Diabetic Ulcers, Venous Leg Ulcer, Arterial Leg Ulcer, Pressure Ulcer
- Trial name
- NCT07255937
- Testing
- Debridement Pad
- Where
- Spain
- Volunteers
- 184 people
- Sponsor
- Advanced Medical Solutions Ltd.
Cervical Spondylosis, Cervical Radiculopathy
NuVasive® ACP System Study
The primary objective of this study is to evaluate the safety and performance of anterior cervical spine surgery using the NuVasive anterior cervical plate (ACP) System as measured by reported complications, radiographic…
- Conditions
- Cervical Spondylosis, Cervical Radiculopathy, Cervical Myelopathy, Cervical Disc Disease
- Trial name
- NCT05066711
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- NuVasive
Coagulation Defect; Bleeding
Quantra QPlus Sample Type Comparison
This is a single center prospective observational study to compare QPlus parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing cardiac surgery.
- Trial name
- NCT05290675
- Testing
- Quantra QPlus System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- HemoSonics LLC
Breast Cancer
Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry
This is a minimal risk post-market registry study conducted at participating clinical institutions that are utilizing LumiSystem consistent with the U.S.
- Trial name
- IMPACT (NCT07616856)
- Where
- 2 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Lumicell, Inc.
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.
Cataract
Safety and Effectiveness of the Opira AIOL in Comparison to Commercial IOLs in Patients Undergoing Cataract Surgery
This is a clinical trial comparing an investigative accommodative IOL and two commercial IOLs in patients with cataracts undergoing primary cataract surgery.
- Trial name
- NCT04756908
- Testing
- Cataract Surgery
- Where
- 2 sites in Costa Rica, Mexico
- Volunteers
- 200 people
- Sponsor
- FSV6, Ltd.
Orthopedic Surgery, General Anesthesia
Comparison Study of Intraoperative Patient Warming Systems
Medications used to put people to sleep during surgical procedures also cause changes in the body's ability to control its temperature. These changes can make a person's temperature drop below normal.
- Trial name
- NCT00670826
- Testing
- vitalHEAT vH2 Temperature Management System, Arizant Healthcare Bair Hugger Temperature Management System
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Dynatherm Medical Inc.