Clinical trials: Surgical Performance
Cataract, Lens Opacities
Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery
Controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study to investigate visual performance after implantation of a trifocal IOL (PhysIOL Pod L GF) in patients that underwent refractive…
- Conditions
- Cataract, Lens Opacities, Presbyopia
- Trial name
- NCT04054427
- Testing
- IOL implantation experimental
- Volunteers
- healthy volunteers welcome
- Sponsor
- Beaver-Visitec International, Inc.
Cardiac Surgery, Heart Surgery
Safety and Performance Evaluation of CPB Venous and Arterial Cannulas
This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety.
- Conditions
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Coronary Surgery
- Trial name
- NCT07354841
- Testing
- Eurosets Venous and Arterial Cannula, Control Arterial and Venous Cannulas
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Eurosets S.r.l.
Breast Implant Revision, Breast Augmentation Complications
Scaffold-guided Breast Implant Revision and Primary Breast Augmentation Surgery
The objective of the clinical investigation is to demonstrate safety and clinical performance of the absorbable polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) for primary breast augmentation…
- Conditions
- Breast Implant Revision, Breast Augmentation Complications, Primary Breast Augmentation Surgery
- Trial name
- NCT07367698
- Testing
- Implantation of the PCL Breast scaffold with autologous fat grafting
- Where
- 3 sites in Australia
- Volunteers
- 87 people
- Sponsor
- BellaSeno Pty Ltd
Robotic-assisted Soft-tissue Surgery
Versius Robotic Surgery in the NHS: A Multi-Specialty Retrospective Study
To generate robust, real-world comparative evidence on the short and long-term clinical outcomes following surgical intervention with Versius Robot-Assisted Surgery versus surgical standard of care across predefined soft-tissue…
- Trial name
- NCT07761299
- Where
- 5 sites in United Kingdom
- Volunteers
- 1,200 people
- Sponsor
- CMR Surgical Ltd
Lung Cancer
A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies
This Phase 2 study is an open-label, single-arm trial where each patient is his/her own "intrapatient" control. All patients will receive a single dose of pegsitacianine prior to standard of care surgery.
- Trial name
- NCT05048082
- Testing
- pegsitacianine, Tumor resection surgery
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- OncoNano Medicine, Inc.
Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis
Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty
This long-term outcomes study is designed to collect safety and efficacy data on designated, commercially available, hip arthroplasty products.
- Conditions
- Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis, Femur Head Necrosis, Congenital Dislocations
- Trial name
- NCT02230826
- Where
- 13 sites in France
- Volunteers
- 2,500 people
- Sponsor
- Corin
Breast Cancer, Head and Neck Squamous Cell Carcinoma
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine…
- Conditions
- Breast Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Prostate Cancer
- Trial name
- NCT03735680
- Testing
- ONM-100
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- OncoNano Medicine, Inc.
Colon Cancer, Rectum Cancer
Phase I of SGM-101 in Patients With Cancer of the Colon, Rectum or Pancreas
This study evaluates the safety and performance of SGM-101, a Carcinoembryonic Antigen (CEA)-specific chimeric antibody conjugated with a NIR emitting fluorochrome, for the visualization of CEA-expressing cancers during surgery.
- Conditions
- Colon Cancer, Rectum Cancer, Pancreas Cancer, Metastatic Colorectal Cancer
- Trial name
- NCT02973672
- Testing
- SGM-101
- Where
- 3 sites in Netherlands
- Volunteers
- 75 people
- Sponsor
- Surgimab
Colorectal Neoplasms
Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.
- Trial name
- NCT03659448
- Testing
- SGM-101
- Where
- 11 sites in United States, Germany and 2 more
- Volunteers
- 300 people
- Sponsor
- Surgimab
Breast Cancer Surgery
Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment
The aim of this exploratory study is to assess the performance and tolerability of the MOBIDERM Intimate Bra in the management of breast edema related to breast cancer treatment.
- Trial name
- MOBIBRA (NCT06303154)
- Testing
- Mobiderm Intimate Bra group
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Thuasne
Rheumatoid Arthritis, Osteoarthritis
Multi-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary Hip Replacement Surgery
The purpose of this study is to monitor the performance of the DeltaMotion cup system in the treatment of patients with hip joint disease requiring a total hip replacement.Patients who enter the study will be evaluated at regular…
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Avascular Necrosis
- Trial name
- NCT01635166
- Testing
- Delta Motion
- Where
- 3 sites in India, United Kingdom
- Volunteers
- 250 people
- Sponsor
- DePuy International
Craniotomy, Duraplasty
Assessment of the Performance of LYoplant® ONlay for Duraplasty
The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.
- Conditions
- Craniotomy, Duraplasty, Spinal Surgery
- Trial name
- LYON (NCT02678156)
- Testing
- Lyoplant Onlay
- Where
- 3 sites in Germany
- Volunteers
- 61 people
- Sponsor
- Aesculap AG
Severe Aortic Stenosis
Colibri Transcatheter Aortic Heart Valve System Study
The Colibri Heart Valve clinical investigation ("COL-01") is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results.
- Trial name
- NCT04029844
- Testing
- Colibri TAVI System
- Where
- 5 sites in France, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Colibri Heart Valve LLC
C.Surgical Procedure; Cardiac, Haemorrhage.
Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery
The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac and aortic thoracic surgery.
- Trial name
- NCT01879475
- Testing
- 032-11, Floseal (R)
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Medtrade
Breast Implant Revision
LTFU of PCL Breast Scaffolds Used in 2021-BRV-004
The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with…
- Trial name
- NCT07383012
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
Ovarian Cancer, Cervical Cancer
Sirius in Gynaecological Laparoscopic Surgery
Precision Robotics' Sirius Robotic Flexible Endoscopic System is a new fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction.
- Conditions
- Ovarian Cancer, Cervical Cancer, Gynecologic Cancer
- Trial name
- NCT05048407
- Testing
- Gynaecological laparoscopic surgery (Sirius System)
- Where
- Hong Kong
- Volunteers
- 30 people
- Sponsor
- Precision Robotics (Hong Kong) Limited
Degenerative Disc Disease, Spinal Stenosis
New Robotic Assistance System for Spinal Fusion Surgery
The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis
- Trial name
- AQrate (NCT02558621)
- Testing
- AQrate Robotic Assistance System
- Where
- 2 sites in Switzerland
- Volunteers
- 24 people
- Sponsor
- KB Medical SA
Medial Malleolus Fracture, Lisfranc Injury
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations…
- Conditions
- Medial Malleolus Fracture, Lisfranc Injury, Lisfranc Fracture, Talus Fracture
- Trial name
- NCT05555459
- Testing
- Operation
- Where
- Finland
- Volunteers
- 125 people
- Sponsor
- Inion Oy
Surgical Operation, Edentulous Jaw
Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants
This Post-Market Clinical Follow-Up study aims to document the success and survival of the Axiom® BL X3 Implants up to 3 years after loading.
- Conditions
- Surgical Operation, Edentulous Jaw, Edentulous Mouth, Implant
- Trial name
- Prospective_X3 (NCT05768295)
- Testing
- Axiom BL X3
- Where
- 13 sites in France
- Volunteers
- 200 people
- Sponsor
- Anthogyr
Cardiac Surgery, Heart Surgery
Novel Venous Cannula Trial
This is a prospective, open-label, single-arm, single-center clinical investigation designed to evaluate the safety and performance of a Novel Venous Cannula during on-pump cardiac surgery requiring transfemoral venous…
- Conditions
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Minimally Invasive Surgical Procedures
- Trial name
- NCT07087639
- Testing
- Self-expanding Venous Cannula
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- Eurosets S.r.l.