DRKS00017490
Completed
未知
Prospective, monocentric, single-arm study investigating the safety and efficacy of local ablation of symptomatic uterine fibroids with US-guided high-Intensity focused ultrasound (HIFU) - HIFU-MT16
niversitätsklinikum Bonn0 sites20 target enrollmentMay 10, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- D25.1
- Sponsor
- niversitätsklinikum Bonn
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written documented informed consent to participate in the study
- •\-Patients who are able to follow study instructions and are likely to attend all required study visits (compliance)
- •\-Patients with symptomatic uterine fibroids who refuse surgical therapy and patients with increased risk of perioperative morbidity
- •\-Symptomatic uterine fibroid patients with indication for HIFU treatment
- •\-The uterine fibroid can be adequately visualized sonographically in the abdominal/back position and has a minimal diameter of 2 cm, no evidence of malignancy on imaging
- •\-Safe acoustic access to the fibroid is available
- •\-Distance between the skin surface and the deepest focus in the tumor max. 11 cm
- •\-MRI suitability of the patient
Exclusion Criteria
- •\- Age \<18 years
- •\- Pregnancy or breastfeeding period
- •\- Suspected malignancy
- •\- Pathological cancer screening smear
- •\- Acute cystitis
- •\- Acute infection (e.g. pneumonia)
- •\- Pedunculated fibroids, subserous fibroids
- •\- Kelloid of the skin or in the acoustic access pathway
- •\- Ileal conduit
- •\- Concurrent participation in a clinical trial with ingestion of an investigational product up to 30 days prior to participation in this clinical trial
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 4
A study to assess result after shoulder surgeryHealth Condition 1: M999- Biomechanical lesion, unspecifiedCTRI/2023/04/052027Healthium Medtech Limited
Active, not recruiting
Phase 4
A study to assess result after knee surgeryHealth Condition 1: - Health Condition 2: M999- Biomechanical lesion, unspecifiedCTRI/2023/04/051727Healthium Medtech Limited
Recruiting
Phase 4
A study to assess result after shoulder surgeryHealth Condition 1: M999- Biomechanical lesion, unspecifiedCTRI/2023/07/055473Healthium Medtech Limited
Active, not recruiting
Not Applicable
An open, prospective, single-arm study investigating safety and efficacy of the human hepatitis B immunoglobulin BT088 after subcutaneous application in liver transplanted patientsClinical Phase: III - STUDY 974PROPHYLAXIS OF HEPATITIS B REINFECTION AFTER LIVER TRANSPLANTATIONMedDRA version: 9.1Level: LLTClassification code 10058827Term: Hepatitis B reactivationEUCTR2008-007625-39-ITBiotest AG130
Active, not recruiting
Not Applicable
sing Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) PatientsMultiple SclerosisMedDRA version: 17.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2013-001439-34-DEGenzyme Corporation1,000