Clinical trials: Access Complication
Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of…
- Conditions
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- Trial name
- EAP (NCT01701947)
- Testing
- Hemoleven
- Where
- United States
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Non-Muscle Invasive Bladder Neoplasms
Pre-Approval Expanded Access Study for TAR-200 Treating Physician Use
The purpose of this pre-approval access program is to provide access to TAR-200 prior to its marketing authorization for the treatment of participant(s) with high-risk non-muscle invasive bladder cancer (HR-NMIBC).
- Trial name
- NCT06877676
- Testing
- TAR-200
- Sponsor
- Janssen Research & Development, LLC
Vascular Access Complications
Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters.
- Trial name
- NCT01940354
- Testing
- AccuCath IV Catheter System, Conventional IV Catheter System
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
End Stage Renal Disease, End Stage Renal Failure on Dialysis
First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft
A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.
- Trial name
- aXess-FIH (NCT04898153)
- Testing
- aXess
- Where
- 6 sites in Belgium, Italy and 2 more
- Volunteers
- 20 people
- Sponsor
- Xeltis
Vascular Access Complication
AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and…
- Trial name
- NCT01943474
- Testing
- AccuCath IV Catheter Device, Conventional IV Catheter Device
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- C. R. Bard
Dialysis Access Malfunction, Dialysis; Complications
Dialysis Access Monitoring Using a Digital Stethoscope-Based Deep Learning System
This study will enroll end-stage renal disease (ESRD) patients on hemodialysis with a maturing arteriovenous fistula (AVF) for hemodialysis access.
- Trial name
- NCT05105503
- Testing
- Eko CORE Digital Stethoscope
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Eko Devices, Inc.
End Stage Renal Disease
Adenovirus Vascular Endothelial Growth Factor (VEGF) Therapy in Vascular Access - Novel Trinam AGainst Control Evidence
Patients in renal failure on hemodialysis depend on adequate and sustained vascular access. This can be achieved by surgical placement of a synthetic polytetrafluoroethylene (PTFE) graft.
- Trial name
- AdV-VANTAGE (NCT00895479)
- Testing
- Graft placement surgery plus Trinam therapy
- Where
- 12 sites in United States
- Volunteers
- 250 people
- Sponsor
- Ark Therapeutics Ltd
X-linked Hypophosphatemia, Tumor-Induced Osteomalacia
Expanded Access to Burosumab
Individual patient expanded access requests may be considered for patients who have no other treatment options
- Trial name
- NCT03775187
- Testing
- Burosumab
- Sponsor
- Kyowa Kirin Co., Ltd.
Postpartum Depression
Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression
This is an expanded access program intended to provide access to ZULRESSO™ (brexanolone) injection for the treatment of a limited number of eligible women with postpartum depression during the period prior to commercial…
- Trial name
- NCT03924492
- Testing
- ZULRESSO (brexanolone) injection
- Sponsor
- Supernus Pharmaceuticals, Inc.
Carcinoma, Renal Cell
Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program
This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational study for patients with unresectable or…
- Trial name
- NCT01412671
- Testing
- Sorafenib (Nexavar, BAY43-9006)
- Where
- Japan
- Volunteers
- 117 people
- Sponsor
- Bayer
Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma
An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.
- Conditions
- Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma, Urologic Cancer, Bladder Cancer
- Trial name
- NCT06443944
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 27 sites in United States
- Sponsor
- CG Oncology, Inc.
Clear Cell Renal Cell Carcinoma
A Study of Theranostic Pair PD-32766D/T in Participants With Carbonic Anhydrase IX Positive Clear Cell Renal Cell Carcinoma
This is an open-label, multicenter, Phase 1a/1b study evaluating the theranostic pair 64Cu-PD-32766 Injection (PD-32766D) and 225Ac-PD-32766 Injection (PD-32766T) in adult patients with relapsed or refractory Carbonic Anhydrase…
- Trial name
- NCT07688187
- Testing
- PD-32766D (a Copper-64 [64Cu] labeled peptide), PD-32766T (an Actinium-225 [225Ac] labeled peptide)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- PeptiDream Inc.
Complication of Renal Dialysis, End Stage Renal Disease
A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS2 (NCT05425056)
- Testing
- Sirolimus
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 136 people
- Sponsor
- Vascular Therapies, Inc.
Intravenous Access, Medical Device
Safe-Infusion Study
Around 1.5 billion peripheral intravenous catheters (PIVCs) are sold yearly, with up to 90% of hospitalized patients receiving one, yet failure rates can reach 69%, often due to phlebitis, infiltration, occlusion, or…
- Trial name
- NCT06727240
- Testing
- Intervention
- Where
- 2 sites in Portugal, Spain
- Volunteers
- 548 people
- Sponsor
- Interlinked AB
Low Grade Ovarian Serous Adenocarcinoma, Ovarian Cancer
Continued Access to Avutometinib in Combination With Defactinib in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
This Open-Label Extension (OLE) study provides participants with recurrent low-grade serous ovarian cancer (LGSOC) who have completed the VS-6766-201(RAMP-201) study continued, uninterrupted access to avutometinib in combination…
- Trial name
- NCT07747506
- Testing
- avutometinib + defactininb combination
- Where
- 2 sites in France
- Volunteers
- 2 people
- Sponsor
- Verastem, Inc.
End Stage Renal Disease, AV Fistula
Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD
A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.
- Conditions
- End Stage Renal Disease, AV Fistula, Fistula, End Stage Kidney Disease
- Trial name
- NCT02363972
- Testing
- Ellipsys Vascular Access Catheter
- Where
- 5 sites in United States
- Volunteers
- 103 people
- Sponsor
- Medtronic Endovascular
End Stage Renal Disease
Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access
This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving…
- Trial name
- ACUSEAL (NCT01173718)
- Testing
- GORE® ACUSEAL Vascular Graft
- Volunteers
- 138 people
- Sponsor
- W.L.Gore & Associates
End-Stage Renal Disease
Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
- Trial name
- NCT05880537
- Testing
- Nexeon Arterial Venous Allograft
- Where
- 4 sites in United States
- Volunteers
- 100 people
- Sponsor
- LifeNet Health
Kidney Stone
Robotic-assisted Percutaneous Access
This is a first-in-man (FIM) study to show feasibility and safety profile of the newly developed robotic device for percutaneous access in PCNL surgery.
- Trial name
- NCT04435132
- Testing
- PCL under fluoroscopy with the aid of the robotic device
- Where
- Malaysia
- Volunteers
- 5 people
- Sponsor
- NDR Medical Technology Pte Ltd
Chronic Kidney Diseases, Chronic Kidney Failure
SelfWrap-Assisted Arteriovenous Fistulas
This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs).
- Conditions
- Chronic Kidney Diseases, Chronic Kidney Failure, End Stage Renal Disease, End Stage Kidney Disease
- Trial name
- SW-AVF (NCT05418816)
- Testing
- SelfWrap Bioabsorbable Perivascular Wrap
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- VenoStent