Clinical trials: Upper Limb Surgery
Lymphedema, Edema
Surgical Evaluation for Upper Extremity Lymphedema (BioBridge)
To investigate whether the addition of Fibralign's BioBridge® Collagen Matrix (BioBridge) devices to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the…
- Trial name
- NCT05695924
- Testing
- BioBridge® Collagen Matrix, Vascularized Lymph Node Transfer (VLNT)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Fibralign Corporation
Lymphedema, Lymphedema, Breast Cancer
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of the Dayspring Technology for Patients With Breast Cancer Related Lymphedema (BCRL) After Lymphatic Surgery
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
- Conditions
- Lymphedema, Lymphedema, Breast Cancer, Lymphedema Arm
- Trial name
- TIGRIS (NCT04888975)
- Testing
- Dayspring Active Wearable Compression System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Koya Medical, Inc.
Glioblastoma Multiforme (GBM)
JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)
This study was designed to evaluate the safety, tolerability, efficacy and pharmacokinetics of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and concomitant…
- Trial name
- NCT06595186
- Testing
- JK-1201I, Temozolomide (TMZ)
- Where
- China
- Volunteers
- 25 people
- Sponsor
- JenKem Technology Co., Ltd.
Hernia
A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft
This study will enroll subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.
- Trial name
- AlloMax (NCT01205399)
- Where
- 5 sites in United States
- Volunteers
- 78 people
- Sponsor
- C. R. Bard
Aneurysmal Subarachnoid Hemorrhage
Evaluation of the Efficacy and Safety of Clazosentan in Reversing Cerebral Vasospasm in Adult Subjects With Aneurysmal Subarachnoid Hemorrhage
The purpose of this study is to evaluate the safety and potential therapeutic benefit of use of clazosentan in reversing cerebral vasospasm (a narrowing of blood vessels in the brain due to the presence of blood in the space…
- Trial name
- REVERSE (NCT02560532)
- Testing
- Clazosentan
- Where
- 11 sites in Finland, France and 1 more
- Volunteers
- 25 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Liver Resection
Post-Market Clinical Study to Confirm Safety and Performance of PuraStat Absorbable Haemostatic Material for the Management of Bleeding in Liver Surgery
The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.
- Trial name
- NCT03600168
- Testing
- PuraStat®
- Where
- United Kingdom
- Volunteers
- 80 people
- Sponsor
- 3-D Matrix Europe SAS
Hemostasis, General Surgery
A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
The Study investigates a new product, sFilm-FS, aimed to help controlling body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.
- Trial name
- NCT04660721
- Testing
- sFilm-FS, TACHOSIL®
- Where
- 4 sites in United States, Austria and 1 more
- Volunteers
- 33 people
- Sponsor
- Sealantium Medical Ltd.
Full-thickness Rotator Cuff Tear
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
- Trial name
- NCT02208440
- Testing
- Best Repair of torn Rotator Cuff, InSpace™ system
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- OrthoSpace Ltd.
Breast Neoplasm
SAVI SCOUT Clinical Evaluation Study
The purpose of this study is to evaluate the performance of the SAVI SCOUT® Surgical Guidance System (SAVI SCOUT). The SAVI SCOUT is a medical device, used to provide real-time guidance during localized excisional biopsy or…
- Trial name
- NCT02370082
- Testing
- Localization of breast lesion
- Volunteers
- 150 people
- Sponsor
- Cianna Medical, Inc.
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
Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery.
This study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months post operation as well as the safety over a period of 6 months, by preventing sternal infection post cardiac surgery in patients above…
- Trial name
- NCT02731573
- Testing
- D-PLEX, Open heart surgery
- Where
- 5 sites in Israel
- Volunteers
- 81 people
- Sponsor
- PolyPid Ltd.
Cerebrospinal Fluid Leakage
Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy
This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.
- Trial name
- NCT01295619
- Testing
- I-020805
- Where
- 4 sites in Germany, Hungary
- Volunteers
- 41 people
- Sponsor
- Kuros Biosurgery AG
Bleeding
ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery - Liver Bleeding is Encountered
Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery in Which Liver Bleeding is Encountered.
- Trial name
- NCT02264730
- Testing
- ClotFoam
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Biomedica Management Corporation
Bladder Urothelial Cancer
An Efficacy and Safety Study of ICP-192 in Subjects With Bladder Urothelial Cancer
This is a phase 2, multicenter, single arm, open-lable study of ICP-192. The purpose of this study is to evaluate efficacy of ICP-192 in subjects with surgically unresectable or metastatic bladder urothelial cancer.
- Trial name
- NCT04492293
- Testing
- ICP-192
- Where
- 22 sites in China
- Volunteers
- 115 people
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
Postoperative Pain
Maxigesic® IV Phase 3 Exposure Study
The study aims to determine the tolerability of repeated doses of Maxigesic® IV over an extended period of exposure.
- Trial name
- NCT04005755
- Testing
- Maxigesic® IV
- Where
- 4 sites in United States, New Zealand
- Volunteers
- 232 people
- Sponsor
- AFT Pharmaceuticals, Ltd.
Cholangiocarcinoma
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
The purpose of this study is evaluate the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.
- Trial name
- NCT02924376
- Testing
- Pemigatinib
- Where
- 120 sites in United States, Belgium and 10 more
- Volunteers
- 147 people
- Sponsor
- Incyte Corporation
Failed Back Surgery Syndrome
SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients
The purpose of this study is to compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management (OMM) versus OMM alone in patients suffering from…
- Trial name
- NCT01711619
- Testing
- subcutaneous nerve stimulation, Optimized Medical Management
- Where
- 26 sites in Australia, Austria and 8 more
- Volunteers
- 162 people
- Sponsor
- MedtronicNeuro
Acute Coronary Syndrome
Ticagrelor Removal Study Using CytoSorb® 300 mL Device During CPB in Patients Undergoing Emergent Cardiothoracic Surgery
The aim of CyTation is to demonstrate intra-operative removal of ticagrelor by CytoSorb® hemadsorption in patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB, using platelet reactivity to adenosine…
- Trial name
- CyTation (NCT04625764)
- Testing
- Blood sampling and analysis
- Where
- 4 sites in Germany, Luxembourg
- Volunteers
- 6 people
- Sponsor
- CytoSorbents Europe GmbH
Musculoskeletal Diseases
Medacta NextAR TKA Pivotal Trial
The goal of this study is to assess the efficacy and safety of a navigation system providing personalized soft tissue balance data in medially-stabilized total knee arthroplasty (TKA).
- Trial name
- NCT04844879
- Testing
- NextAR TKA system
- Where
- 4 sites in Switzerland
- Volunteers
- 40 people
- Sponsor
- Medacta International SA
Acute Myocardial Infarction (AMI), Asystole
SPIKE FLOW Endocardial Lead Safety and Performance Study
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: safety in terms of freedom from Serious Adverse Events(SADEs); performance in terms of Mean…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA