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BORIS - aBlação pOR mIcro-ondaS [Microwave Ablation]

NCT04510714 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-03

No results posted yet for this study

Summary

Patients with sarcoma and lung metastases have few therapeutic options, with poor response to systemic treatment. Many of them are not eligible to surgical treatments due to the high number and distribution of pulmonary lesions or due to comorbidities, which reduce the survival chances of these individuals. Given the high efficacy and overall increased survival demonstrated by recent studies, the minimally invasive treatments (mainly radiofrequency ablation) have gained ground. Although the microwave ablation is a promising new technique for the treatment of patients with pulmonary metastases, there are few studies in the literature to evaluate the efficacy and safety of this procedure in the above population.

Conditions

  • Sarcoma

Interventions

DEVICE

Image guided percutaneous microwave ablation

Lung metastasis from sarcoma will be treated with microwave antennas (SOLERO) and Ablation System and microwave generators (Angiodynamics), with power settings of 35-45W and an average ablation time of 15 minutes (range 10-30 minutes). The ablation time will be recorded for all procedures. The manufacturer's recommendations will be observed in all cases, since it is assured that patients are able to tolerate the total ablation time.

Sponsors & Collaborators

  • Angiodynamics, Inc.

    collaborator INDUSTRY

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Principal Investigators

  • Marcos Roberto de Menezes, MD, PHD · Instituto do Cancer do Estado de Sao Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-04-01
Completion
2025-10-01
FDA Device
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04510714 on ClinicalTrials.gov