Clinical trials: Surgical Performance
Arthritis, Traumatic Arthritis
Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty
The goal of this randomized, controlled, monocentric, single-blind, 2-arm, feasibility clinical investigation is to evaluate the safety of MectaShield hydrogel coating and to capture its preliminary clinical performance in the…
- Conditions
- Arthritis, Traumatic Arthritis, Avascular Necrosis
- Trial name
- NCT05679232
- Testing
- Hydrogel coating, Control
- Where
- Austria
- Volunteers
- 56 people
- Sponsor
- Medacta International SA
Aphakia, Astigmatism
Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix
The purpose of this Post-Market Clinical Follow-up study is to describe the long-term safety and performance of the Clareon Vivity and Vivity Toric and Clareon PanOptix and PanOptix Toric IOLs.
- Conditions
- Aphakia, Astigmatism, Presbyopia
- Trial name
- NCT05796453
- Testing
- Clareon Vivity IOL - Non Toric, Clareon Vivity IOL - Toric, Clareon PanOptix Trifocal IOL - Non Toric
- Where
- 7 sites in United States, Puerto Rico
- Volunteers
- 470 people
- Sponsor
- Alcon Research
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
Guided Bone Regeneration
Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
The goal of this observational study is to measure in real practice the performance and safety of RTR+Membrane, a synthetic dental membrane for guided tissue regeneration in periodontal or dental implant surgery.
- Trial name
- ObsR+ (NCT06467630)
- Testing
- Preserving alveolar bone volume after tooth extraction, Alveolar crest reconstruction, Covering bone defects during immediate implant placement.
- Where
- 9 sites in France
- Volunteers
- 90 people
- Sponsor
- Septodont
Surgery
EEG Data Collection to Evaluate New Patient State Index Performance
This is a prospective, single-center, cohort study in patients undergoing surgical procedures to collect data using Masimo SedLine EEG device in order to evaluate a newer version of PSI measurement against an older version of PSI…
- Trial name
- NCT02954952
- Testing
- PSI Rev 1.X, PSI Rev 2.X
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Masimo Corporation
Osteolysis, Arthroplasty Complications
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
- Conditions
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis
- Trial name
- NCT04255966
- Testing
- Plasmafit® Revision Structan®
- Where
- 4 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
Oncoplastic Breast Surgery, Bilateral Surgery
A Clinical Study to Assess the Safety and Clinical Performance of a New Dressing (PICO7Y) in Breast Surgery Patients
The purpose of the study is to assess the use of a wound dressing system called PICO7Y following a two-sided breast surgery. PICO7Y is a new dressing system made to treat two incisions/wounds at the same time, and the purpose of…
- Trial name
- PICO7Y (NCT03835845)
- Testing
- PICO7Y
- Where
- 5 sites in Netherlands, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
Wound Closure, Dehisced Surgical Wounds
Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives
surgical adhesive systems are used to close surgical cuts and simple skin wounds. This system is a non-invasive option, meaning it can be used instead of stitches or staples.
- Trial name
- NCT07613892
- Testing
- Evaluating wound closure products to close larger surgical site incisions, Evaluating wound closure products to close smaller surgical site incisions
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Medline Industries
Cataract
The Usefulness of Visuprime in Cataract Surgery
This is a multicentre, post-market, open label, randomized, placebo-controlled prospective study exploring the performance of Visuprime in improving ocular surface homeostasis and reducing conjunctival bacterial load in patients…
- Trial name
- NCT06533995
- Testing
- Visuprime
- Where
- 2 sites in Italy
- Volunteers
- 75 people
- Sponsor
- VISUfarma SpA
Hip or Knee Surgery
Post Market Clinical Follow-up Study
The overall rationale for this study is to evaluate the clinical performance potential for Mepilex Border Post-Op in the ability to minimise the risk of blistering, maceration and less dressing change due to high absorption…
- Trial name
- MxB Po01 (NCT01841567)
- Testing
- Mepilex border post. op, Mepilex border post op
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Molnlycke Health Care AB
Cataracts
A Real-World Registry to Investigate the Performance of LenSx® Laser in Chinese Patients
The purpose of this study is to investigate the performance of LenSx® Laser in femtosecond laser-assisted cataract surgery (FLACS) in real-world medical practice in Chinese patients.
- Trial name
- NCT02396719
- Testing
- LenSx® Laser
- Where
- China
- Volunteers
- 1,541 people
- Sponsor
- Alcon Research
Cataract Extraction, Corneal Astigmatism
Assessment of Visual Performance in Patients With Low Levels of Astigmatism
To assess visual performance in patients with low levels (0.5-0.75 Diopters) of corneal astigmatism.
- Trial name
- NCT00842231
- Testing
- Visual performance measures
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Alcon Research
Transforaminal Lumbar Interbody Fusion Surgery
The Objective of the Protocol is to Generate Real World Evidence (RWE) Supporting the Safety, Performance, and Health Economics of Using the Regulatory Approved and Commercially Available EARP Interbody System Used During Lumbar Interbody Fusion (LIF) Procedures With the EARP Nerve Cuff Electrode
The goal of the trial is to generate data to support the safety, performance, and cost effectiveness of using the EARP devices during Lumbar Interbody Fusion (LIF) procedures.
- Trial name
- EARP-2 (NCT07020000)
- Testing
- Device: Nerve Cuff and Retractor System
- Where
- 5 sites in United States
- Volunteers
- 120 people
- Sponsor
- Retropsoas Technologies, LLC
Following Cataract Surgery
Performance and Safety of Routine Cataract Surgery With Visiol
In this clinical investigation, the performance and safety of routine cataract surgery with VISIOL will be assessed
- Trial name
- NCT04866706
- Testing
- Visiol
- Where
- Thailand
- Volunteers
- 100 people
- Sponsor
- TRB Chemedica
Cardiac Surgery
Performance of Pulse Oximeter Sensors in Neonates
Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.
- Trial name
- NCT03870373
- Testing
- Pulse Oximeter
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Taiwan Aulisa Medical Devices Technologies, Inc.
Surgery, Orthognathic Surgery
Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming.
- Conditions
- Surgery, Orthognathic Surgery, Orthognathic Surgical Procedures
- Trial name
- NCT05073757
- Testing
- Custom-made guides and plates
- Where
- 4 sites in Belgium, France
- Volunteers
- 56 people
- Sponsor
- Global D
Wound Healing and Prevention
Performance, Safety and Efficacy of NPWT Device
Smith \& Nephew are assessing a new investigational single use NPWT system.
- Trial name
- NCT04102865
- Testing
- Negative-Pressure Wound Therapy (NPWT)
- Where
- 8 sites in United Kingdom
- Volunteers
- 90 people
- Sponsor
- Smith & Nephew, Inc.
Abdominal Vascular Surgery, Peripheral Vascular Surgery
A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C
Purpose of the study is to describe safety and performance of POLYMAILLE® C from a minimum of 200 subjects will be evaluated. A minimum of 100 subjects will be evaluated for each main location of surgery (abdominal and…
- Conditions
- Abdominal Vascular Surgery, Peripheral Vascular Surgery, Vascular Prothesis, Aneurysm Abdominal
- Trial name
- NCT05517876
- Testing
- Vascular abdominal or peripheral surgery
- Where
- France
- Volunteers
- 212 people
- Sponsor
- Perouse Medical
Sternum Closure
STEELEX® Sternum Set + BONE WAX® + STEELEX® Electrode Set in Patients Undergoing Cardiac Surgery
The aim of the study is to assess the effectiveness and performance of using STEELEX® Sternum Set, BONE WAX® and STEELEX® Electrode Set in patients undergoing cardiac surgery.
- Trial name
- STEADY (NCT06065800)
- Testing
- STEELEX® Sternum Set
- Where
- Spain
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Bone Substitutes, Bone Defect
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)
Multi-center, international, prospective, open-label, single-arm, first-in-human clinical investigation. The Patients enrolled in this clinical investigation will undergo a scheduled surgery for the treatment of long bone defects…
- Trial name
- NCT03884790
- Testing
- surgical repair of long bone defects
- Where
- 8 sites in Bosnia and Herzegovina, Israel and 4 more
- Volunteers
- 16 people
- Sponsor
- GreenBone Ortho S.p.A.