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Operator and Patient Acceptance of Radiofrequency Cautery of the Biopsy Track During Percutaneous Liver, Kidney or Spleen Biopsy Procedures.

NCT05790109 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-11-03

No results posted yet for this study

Summary

The goal of this study is to assess the physician and patient experience of radio frequency (RF) track cautery in patients undergoing needle biopsy of the liver, kidney, or spleen who have one or more risk factors for biopsy-related bleeding. RF track cautery involves inserting a bipolar electrode through the same introducer needle used for the biopsy, and heating the tissues along the path of the biopsy needle to prevent bleeding. This study primarily aims to assess the operator and patient experience during the use of track cautery. Secondary aims are to assess the technical success rate and procedure adverse events. Participants who enroll in the study will undergo track cautery as part of their clinically indicated liver, kidney, or spleen biopsy. After the procedure, they will fill out a brief survey asking about their experience during the procedure. Physician operators who perform track cautery as part of the study will also fill out a survey after each procedure asking about their experience using this technique.

Conditions

Interventions

DEVICE

RF track cautery during percutaneous organ biopsy

After biopsy samples are obtained, the physician operator will place a radiofrequency bipolar cautery electrode through the biopsy introducer needle into the biopsy track and cauterize the track using a standardized protocol.

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Paul B Shyn, M.D. · Brigham and Women's Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05790109 on ClinicalTrials.gov