Clinical trials: Surgical Performance
Glaucoma, Open Angle Glaucoma
Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.
- Trial name
- NCT04773106
- Testing
- ARGOS-SC suprachoroidal pressure sensor
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 22 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Cataract
Cataract Surgery: Femto LDV Z8 Versus Conventional
The aim of the study is to demonstrate the performance and safety of the Femtosecond laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV Z8 compared to conventional technique in cataract…
- Trial name
- COMFORT (NCT02351271)
- Testing
- Femto LDV Z8, Manual capsulorhexis&lens fragmentation
- Volunteers
- 130 people
- Sponsor
- Ziemer Ophthalmic Systems AG
Single Ventricle Heart Disease After Fontan Surgery
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular…
- Trial name
- NCT02201342
- Testing
- Udenafil
- Where
- 6 sites in United States, Canada
- Volunteers
- 36 people
- Sponsor
- Mezzion Pharma Co. Ltd
Breast Cancer Female
A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure.
- Trial name
- NCT03300206
- Testing
- Breast Biopsy
- Where
- 7 sites in United States
- Volunteers
- 525 people
- Sponsor
- Hologic, Inc.
Aphakia, Astigmatism
Evaluation of Long-term Safety and Performance of PanOptix Trifocal Intraocular Lens (IOL)
The purpose of this Post-Market Clinical Follow-up (PMCF) study is to describe the long-term safety and performance of the AcrySof IQ PanOptix IOL toric and non-toric models in subjects bilaterally implanted with these IOLs for 3…
- Conditions
- Aphakia, Astigmatism, Presbyopia
- Trial name
- NCT06166901
- Testing
- AcrySof IQ PanOptix IOL Toric, AcrySof IQ PanOptix IOL Non-Toric
- Where
- 7 sites in Spain
- Volunteers
- 211 people
- Sponsor
- Alcon Research
Sleep Apnea, Hypertension
Tri Staple Technology Stapler Used in Gastric Bypass
The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.
- Conditions
- Sleep Apnea, Hypertension, Hyperlipidemia, Coronary Artery Disease
- Trial name
- NCT01026103
- Testing
- Tri Staple Technology stapler
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Glaucoma, Open Angle Glaucoma
Performance and Safety of the ARGOS-SC Suprachoroidal Pressure Sensor in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery
The purpose of this study is to evaluate both the safety and feasibility of the surgical implantation of the ARGOS-SC implant during non-penetrating glaucoma surgery and the safety and usability of the ARGOS-SC implant and system…
- Trial name
- ARGOS-SC01 (NCT03756662)
- Testing
- ARGOS-SC suprachoroidal pressure sensor
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Implandata Ophthalmic Products GmbH
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
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.
Diaphragm Pacing
Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures
Feasibility study to advance the development of NeuRx Diaphragm Pacing System (DPS) for the intended use of stimulating the diaphragm to provide respiratory assistance in patients at risk of prolonged mechanical ventilation in…
- Trial name
- NCT02410798
- Testing
- TransLoc electrode
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Synapse Biomedical
Breast Cancer
CairnSurgical Breast Cancer Locator (BCL) Post-Market Study
This interventional, post-market, multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device, "the Breast Cancer Locator (BCL)" in Subjects with non-palpable breast cancer, in…
- Trial name
- NCT06461663
- Testing
- Breast Cancer Locator Guided Breast Conserving Surgery
- Where
- 6 sites in Germany, Italy and 1 more
- Volunteers
- 35 people
- Sponsor
- CairnSurgical, Inc.
Arthroplasty, Replacement
To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.
To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.
- Conditions
- Arthroplasty, Replacement, Knee
- Trial name
- NCT04849884
- Testing
- CORI™ KNEE TENSIONER
- Where
- 4 sites in United States
- Volunteers
- 77 people
- Sponsor
- Smith & Nephew, Inc.
Open Surgery, Blood Vessels, Lymphatic Ducts and Nerves
PRIMO Post-Market Clinical Follow Up Study
Post Market Clinical Follow up Study aimed to collect clinical data on safety and efficacy of Robotically Assisted System called Symani to perform microsurgery techniques such as anastomosis, suturing and ligation for open…
- Conditions
- Open Surgery, Blood Vessels, Lymphatic Ducts and Nerves, Free Flaps
- Trial name
- PRIMO (NCT04843436)
- Testing
- Symani Surgical System
- Where
- 10 sites in Austria, Belgium and 5 more
- Volunteers
- 427 people
- Sponsor
- MMI (Medical Microinstruments, Inc.)
Chronic Sinusitis
Safety and Performance of the Steroid-Releasing S8 Sinus Implant
The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.
- Trial name
- S8PK (NCT01894503)
- Testing
- S8 Sinus Implant (mometasone furoate, 1350 mcg)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Intersect ENT
Mitral Regurgitation, Mitral Insufficiency
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in…
- Trial name
- NCT04161079
- Testing
- Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Surgical Scar, Breast Augmentation
Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift
Evaluator-blinded study of the safety and performance of fractional radiofrequency (FRF) for the treatment of surgical scars following breast augmentation, abdominoplasty or facelift.
- Conditions
- Surgical Scar, Breast Augmentation, Abdominoplasty, Face Lift
- Trial name
- NCT03467724
- Testing
- Fractional Radiofrequency (FRF)
- Where
- Spain
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
Breast Cancer Female
Brevera™ Breast Biopsy System Data Collection Study
The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure.
- Trial name
- NCT03456583
- Testing
- Brevera Breast Biopsy System
- Where
- 6 sites in France, Germany and 4 more
- Volunteers
- 500 people
- Sponsor
- Hologic, Inc.
Iliac Crest Harvesting Procedure-Bone Void Filler
Study Performance of The Plexur P™ Bone Void Filler Device in Patients Undergoing Iliac Crest Harvesting Procedures
The purpose of this study is to determine if Plexur P grows bone in the iliac crest (where bone was removed or "harvested") for the back surgery. The study will be focusing on patients who require back surgery.
- Trial name
- NCT00837473
- Testing
- Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Osteotech, Inc