ACTRN12619000536167
Completed
未知
A Prospective, Single-arm, Multicenter Study to Evaluate the Safety and Performance of the Instylla Hydrogel Embolic System (HES) For Patients Requiring Vascular Embolization Alone or in the Pre-operative Setting for Treatment of Malignant and Benign Hypervascular Tumors, and Select Non-Traumatic End-Organ Infarct.
ConditionsPatients Requiring Vascular Embolization Alone for Treatment of Malignant TumorsPatients Requiring Vascular Embolization in the Pre-operative Setting for Treatment of Malignant TumorsPatients Requiring Vascular Embolization Alone for Treatment of Benign Hypervascular TumorsPatients Requiring Vascular Embolization in the Pre-operative Setting for Treatment of Benign Hypervascular TumorsPatients Requiring Vascular Embolization for Select Non-Traumatic End-Organ InfarctCancer - LiverCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemCancer - BoneCancer - Kidney
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Patients Requiring Vascular Embolization Alone for Treatment of Malignant Tumors
- Sponsor
- Instylla Inc
- Enrollment
- 8
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients age greater than or equal to 18 years old
- •2\. Embolization of hypervascular lesion is clinically indicated
- •3\. Expected life expectancy greater than or equal to 6 months after embolization
Exclusion Criteria
- •1\. Ongoing adverse effect that may confound the evaluation of the Instylla HES
- •2\. Pregnant or breast\-feeding, or females planning on becoming pregnant within the next 6 month
- •3\. The patient has other concurrent conditions that in the opinion of the Investigator would be unlikely to receive clinical benefit from the study procedure or participation in the study may compromise patient safety or study objectives (including but not limited to ongoing infection, renal dysfunction, morbid obesity)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Phase 4
A study of Romiplostim Powder for Injection in patientsCTRI/2021/08/035609Intas Pharmaceuticals Limited
Not yet recruiting
Phase 4
The aim is to evaluate the safety and efficacy of MeRes100™ Sirolimus Eluting BioResorbable Vascular Scaffold in coronary artery disease patients.It enhances coronary luminal diameter in symptomatic ischemic heart disease, addressing de novo lesions in native coronary arteries.Health Condition 1: I251- Atherosclerotic heart disease of native coronary arteryCTRI/2024/02/062438Meril Diagnostics Private Limited
Completed
Not Applicable
OFT-G1-301 StudyCongenital heart diseaseJPRN-jRCT1080224691TEIJIN LIMITED / TEIJIN PHARMA LIMITED30
Active, not recruiting
Not Applicable
A multi-center, open-label, single-arm study to evaluate hormone and lipid levels in male subjects with partial onset seizures after a switch of treatment from carbamazepine as adjunctive treatment to levetiracetam to lacosamide as adjunctive treatment to levetiracetam.EUCTR2010-022534-84-DECB Pharma SA28
Active, not recruiting
Not Applicable
A multi-center, open-label, single-arm study to evaluate hormone and lipid levels in male subjects with partial onset seizures after a switch of treatment from carbamazepine as adjunctive treatment to levetiracetam to lacosamide as adjunctive treatment to levetiracetam.Epilepsy: partial onset seizures.MedDRA version: 14.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2010-022534-84-ATCB Pharma SA28