Clinical trials: Malformation
Venous Malformation, Lymphatic Malformation
First in Human Trial of Topical VT30 in Pts With Venous/Lymphatic Malformations Assoc With PIK3CA or TEK Gene Mutations
VT30-101 is a 2-part first-in-human trial of topically administered VT30 to subjects with cutaneous venous malformations, lymphatic malformations, or mixed venolymphatic malformations associated with PIK3CA or TEK mutations.
- Conditions
- Venous Malformation, Lymphatic Malformation, Venolymphatic Malformation
- Trial name
- NCT04409145
- Testing
- VT30
- Where
- 15 sites in United States
- Volunteers
- 15 people
- Sponsor
- Venthera, Inc., a BridgeBio company
Intracranial Arteriovenous Malformations
Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations
This clinical trial is to verify the safety and effectiveness of the Non-adhesive Liquid Embolic System(NALES) produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd.
- Trial name
- NCT05058482
- Testing
- embolism
- Where
- 13 sites in China
- Volunteers
- 116 people
- Sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD
Lymphatic Malformation
A Pharmacokinetic, Pharmacodynamic, Safety and Tolerability Study of CERC-006 in Adults With Complex Lymphatic Malformations
The primary objective of this study is to evaluate the safety and tolerability of CERC-006 in adults (aged 18-31 years) with active, moderate to severe complex lymphatic malformations.
- Trial name
- NCT04994002
- Testing
- CERC-006
- Where
- 3 sites in United States
- Sponsor
- Avalo Therapeutics, Inc.
Cerebral Arteriovenous Malformations
Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs
To assess safety and efficacy of ONYX treatment for cAVM:
- Trial name
- cAVM (NCT02180958)
- Where
- 17 sites in France
- Volunteers
- 140 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Dural Arteriovenous Fistula
PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF
The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.
- Trial name
- NCT03317821
- Where
- 16 sites in Denmark, France and 3 more
- Volunteers
- 70 people
- Sponsor
- Microvention-Terumo, Inc.
Cerebral AV Malformation
PHIL Evaluation in the Endovascular Treatment of Intracranial Cerebral ArterioVenous Malformation (cAVM)
The primary objective of this study is to assess the efficacy and safety of PHIL® liquid embolic agent in endovascular embolization of cerebral arteriovenous malformations.
- Trial name
- NCT03341039
- Where
- 16 sites in Denmark, France and 3 more
- Volunteers
- 20 people
- Sponsor
- Microvention-Terumo, Inc.
Cerebral Arteriovenous Malformation
Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent (CHOICE)
The objective of this study is to further establish that SQUID, an alternative liquid embolic agent with specific properties, is a safe and effective alternative in bAVM endovascular treatment strategy available to date.
- Trial name
- CHOICE (NCT03413852)
- Testing
- SQUID non-adhesive liquid embolic agent
- Where
- 19 sites in Belgium, Denmark and 3 more
- Volunteers
- 111 people
- Sponsor
- Embo-Flüssigkeiten A.G.
Intracranial Aneurysm
Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
The primary objective of this study is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations.
- Trial name
- SMART (NCT02729740)
- Testing
- Penumbra Smart Coil, Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
- Where
- 72 sites in United States, Canada
- Volunteers
- 995 people
- Sponsor
- Penumbra Inc.
Hepatitis B Infection, Congenital Malformation
Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine for Preventing Hepatitis B Vertical Transmission
Immunoprophylaxis with two hepatitis B vaccinations following the hepatitis B immune globulin (HBIg) and hepatitis B vaccine at birth is largely effective in protecting infants from hepatitis B virus (HBV) infection.
- Conditions
- Hepatitis B Infection, Congenital Malformation, Birth Defect, Viremia
- Trial name
- NCT03476083
- Testing
- Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.
- Where
- 7 sites in China
- Volunteers
- 280 people
- Sponsor
- New Discovery LLC
Benign Tumors, Malignant Tumors
Bioseal Dural Sealing Study BIOS-14-001
A Prospective, Randomized, Controlled, Single Blinded, Study to Evaluate the Safety and Effectiveness of Bioseal as an Adjunct to Sutured Dural Repair
- Conditions
- Benign Tumors, Malignant Tumors, Vascular Malformation
- Trial name
- NCT03110783
- Testing
- Bioseal
- Where
- 10 sites in China
- Volunteers
- 200 people
- Sponsor
- Guangzhou Bioseal Biotechnology Co., Ltd.
Cerebral Arteriovenous Malformations
Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent
A non-interventional multicentric study for patients with a cerebral AVM for which endovascular treatment is indicated.
- Trial name
- NCT02602990
- Testing
- SQUID™
- Where
- 6 sites in Belgium, Germany
- Volunteers
- 50 people
- Sponsor
- Emboflu
Arteriovenous Malformations
Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous malformation (AVM) embolization procedures.
- Trial name
- NCT02378883
- Testing
- Apollo™ Onyx™ Delivery Micro Catheter
- Where
- 2 sites in United States
- Volunteers
- 112 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Visceral Artery Aneurysms, Arteriovenous Malformations
Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System
The primary objective of this study is to gather post market data on the Penumbra Ruby Coil System in the treatment of visceral artery aneurysms and arteriovenous malformations.
- Trial name
- NCT02079818
- Testing
- Penumbra Ruby Coil System
- Where
- United States
- Sponsor
- Penumbra Inc.
Aneurysm, Arteriovenous Malformations
Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4
This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4.
- Conditions
- Aneurysm, Arteriovenous Malformations, Arterio-venous Fistula
- Trial name
- NCT03853070
- Testing
- ED Coil / Electro-detach Generator v4
- Where
- 3 sites in Belgium, Germany
- Volunteers
- 100 people
- Sponsor
- Kaneka Corporation
Charcot-Marie-Tooth Disease
A Study to Assess the Safety and Effectiveness of FLX-787 in Subjects With Charcot-Marie-Tooth Disease Experiencing Muscle Cramps.
The COMMIT Study will assess the safety and effectiveness of FLX-787 in men and women with Charcot-Marie-Tooth disease (CMT) experiencing muscle cramps.
- Trial name
- COMMIT (NCT03254199)
- Testing
- FLX-787-ODT (orally disintegrating tablet)
- Where
- 20 sites in United States
- Volunteers
- 27 people
- Sponsor
- Flex Pharma, Inc.
Neural Tube Defects, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
A Study to Evaluate Folate Levels in Women Taking Oral Contraceptives
The purpose of this study is to compare red blood cell folate levels in women who are taking oral contraceptives with or without folic acid
- Conditions
- Neural Tube Defects, Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Nervous System Malformations
- Trial name
- NCT00301587
- Testing
- Norgestimate-ethinyl estradiol, with or without folic acid
- Volunteers
- healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Hypervascular Tumor and Arteriovenous Malformation
A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation
To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in Japanese subjects with hypervascular tumor or arteriovenous malformation
- Trial name
- NCT01677624
- Testing
- E7040
- Where
- 10 sites in Japan
- Volunteers
- 28 people
- Sponsor
- Eisai Co., Ltd.
Hemorrhage, Bleeding
Evaluation of Peripheral EOS for the Peripheral Embolization Treatment to Rapidly OccluDe Venous or Arterial BleEding
To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System.
- Trial name
- OCCLUDE-II (NCT02033954)
- Where
- 7 sites in Austria, Belgium and 1 more
- Volunteers
- 40 people
- Sponsor
- ArtVentive Medical Group, Inc.
Congenital Venous Malformation
Systemic and Local Diffusion of Ethanol After Administration of Ethanol 96% Formulated in a Gel and Ethanol 98% Solution by the Percutaneous Route, in Patients With Congenital Venous Malformations:Pharmacokinetic, Pharmacodynamic and Clinical Study.
Absolute ethanol has been used "off-label" as an unmodified formulation (solution) in Congenital Venous Malformations (CVM). Despite its effectiveness, absolute ethanol appears difficult to handle because of its high diffusion…
- Trial name
- NCT00462462
- Testing
- Ethanol 96% Gel, Ethanol 98% Solution
- Where
- 2 sites in United States, France
- Volunteers
- 32 people
- Sponsor
- Orfagen
Osteoarthritis
Double-Blind,Randomized,Placebo-Controlled Efficacy & Safety Study of EUFLEXXA™ for Treatment of OA of the First CMC
This multicenter, double-blind, randomized, parallel-group, active-controlled trial will be performed in approximately 80 subjects with chronic idiopathic osteoarthritis (OA) of the first carpo-metacarpal joint (CMC).
- Trial name
- NCT00423371
- Testing
- sodium hyaluronate
- Where
- United States
- Volunteers
- 79 people
- Sponsor
- Ferring Pharmaceuticals