Bleeding DisorderNCT05790109
Operator and Patient Acceptance of Radiofrequency Cautery of the Biopsy Track During Percutaneous Liver, Kidney or Spleen Biopsy Procedures.
A study testing RF track cautery during percutaneous organ biopsy in people with Bleeding Disorder and Spleen Lesion, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding Disorder, Spleen Lesion, Liver Diseases
- What is being tested?
- RF track cautery during percutaneous organ biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred to interventional radiology for clinically indicated liver, kidney, or spleen biopsy for diffuse or focal disease, who also have one or more of the following risk factors for bleeding:
- Coagulopathy (INR ≥ 1.5) or thrombocytopenia (platelets < 50) before correction
- Renal disease with glomerular filtration rate (GFR) < 30 ml/min
- Liver cirrhosis
- Anticoagulant or antiplatelet medications where periprocedural withholding poses
- Competing medical risk, or the urgency of the procedure precludes holding the anticoagulant medications for the standard interval (departmental guidelines).
Show all 9Show fewer
- Any splenic biopsy
- Hypervascular masses in the liver or kidney
- Renal and liver parenchymal biopsies, which are known to carry a higher risk of bleeding.
Who cannot join
- Uncorrectable coagulopathy (INR remaining ≥ 2.5) or thrombocytopenia (platelets remaining < 25)
- Pregnancy
- Patients who are not competent to provide their own consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the detailed description
Percutaneous biopsies of abdominal organs (liver, kidney, spleen) are commonly performed procedures and, while generally considered safe, have a small risk of post-biopsy hemorrhage. Bleeding risks of percutaneous biopsy are known to be higher for solid abdominal organs including liver, kidney and spleen, than for abdominal biopsies not involving these organs (for example, peritoneal masses or lymph nodes) Some patients also exhibit an increase in bleeding risk due to alterations in coagulation parameters or platelet number and function, which are known to increase rates of post-biopsy hemorrhage. Existing corrective measures for bleeding diathesis such as blood product transfusions are costly and confer additional risks, and do not address the mechanical tissue and vessel injury that sometimes underlies post-biopsy bleeding. Injection of gelatin sponge or other materials into the biopsy track via the introducer needle, while commonly used, can be cumbersome and imprecise, and has not yet clearly demonstrated a benefit in reducing post-biopsy bleeding in human studies.
High-frequency RF cautery, a technique ubiquitous in modern surgical practice, is routinely used for intraoperative hemostasis. This technique is also routinely used during image-guided percutaneous thermal ablation procedures, where the needle track created by the ablation probe is cauterized during probe retraction. An FDA-cleared bipolar RF cautery device that fits through a 17G biopsy introducer needle is now in clinical use, for the purpose of minimizing bleeding during percutaneous image-guided procedures. This study aims to prospectively study the physician and patient experience of using RF track cautery in patients undergoing percutaneous liver, kidney, or spleen biopsy procedures.
Primary aims of the study are:
- Determine how the use of radiofrequency (RF) track cautery during percutaneous solid organ biopsy affects operator experience.
- Determine how the use of radiofrequency (RF) track cautery during percutaneous solid organ biopsy affects patient experience.
Secondary aims of the study are:
- Determine the technical success rate of RF track cautery during percutaneous solid organ biopsy, defined by successful deployment of the cautery electrode through the biopsy introducer needle and application of radiofrequency current to the biopsy track.
- Monitor adverse events, such as bleeding, during and after biopsy procedures in which RF track cautery is used.
- Conditions
- Bleeding Disorder, Spleen Lesion, Liver Diseases, Kidney Diseases
- Being tested
- RF track cautery during percutaneous organ biopsy
- Keywords
- Biopsy, Cautery, Bleeding, Liver, Kidney, Spleen, Hemostasis
- Medical subject headings
- Hemostatic Disorders, Liver Diseases, Kidney Diseases, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF track cautery during percutaneous organ biopsyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| RF biopsy track cautery | Experimental | This study is designed as an open-label, single arm study, wherein all study participants will undergo RF track cautery during percutaneous liver, kidney, or spleen biopsy. Receives: Device: RF track cautery during percutaneous organ biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient experience during use of radiofrequency track cautery during percutaneous organ biopsy
Patient experience will be assessed via a questionnaire completed while in the recovery area following their procedure. The patient questionnaire will include questions regarding patient recollection of discomfort related to RF cautery, and whether or not they would be willing to have RF cautery performed again during a future biopsy session, if indicated.
Measured: Within 6 hours after procedure
Operator experience during use of radiofrequency track cautery during percutaneous organ biopsy
Operator experience will be assessed via a post-procedure questionnaire (included below) administered to all study operators immediately after they perform each biopsy procedure with RF cautery. The operator questionnaire will consist of a series of questions related to the use of RF cautery, focusing on factors such as ease of use, added procedure time, perceived benefits/detriments, and the operator's perception of associated patient discomfort.
Measured: Within 7 days after procedure
Secondary outcomes (2)
Technical success rate of radiofrequency track cautery during percutaneous organ biopsy
Technical success will be defined by successful deployment of the cautery electrode through the introducer needle into the region sampled by the biopsy needle and application of radiofrequency current for the requisite duration. This will be assessed based on a combination of self-reported technical success by the operator as well as retrospective review of the intraprocedural images by the study investigators.
Measured: Within 7 days after procedure
Adverse events of radiofrequency track cautery during percutaneous organ biopsy
Adverse events will be assessed by recording any major and minor adverse events (including bleeding) that occur during or after biopsy procedures where RF cautery was used.
Measured: Within 30 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start23 May 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Why it stopped: changed study design to retrospective study, since the study intervention is already in routine clinical practice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bleeding DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Paul Bernard Shyn, Brigham and Women's Hospital
- Investigators
- Paul B Shyn, M.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790109
- Sponsor's protocol ID
- 2022P001476
- Status last verified
- Jul 2023
- First submitted
- 14 Mar 2023
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Minami Y, Hayaishi S, Kudo M. Radiofrequency ablation for hepatic malignancies: is needle tract cauterization necessary for preventing iatrogenic bleeding? Dig Dis. 2013;31(5-6):480-4. doi: 10.1159/000355254. Epub 2013 Nov 21.
PubMed 24281024Laeseke PF, Winter TC 3rd, Davis CL, Stevens KR, Johnson CD, Fronczak FJ, Webster JG, Lee FT Jr. Postbiopsy bleeding in a porcine model: reduction with radio-frequency ablation--preliminary results. Radiology. 2003 May;227(2):493-9. doi: 10.1148/radiol.2272020173. Epub 2003 Apr 3.
PubMed 12676970Pritchard WF, Wray-Cahen D, Karanian JW, Hilbert S, Wood BJ. Radiofrequency cauterization with biopsy introducer needle. J Vasc Interv Radiol. 2004 Feb;15(2 Pt 1):183-7. doi: 10.1097/01.rvi.000019398.74740.69.
PubMed 14963187Lim S, Rhim H, Lee MW, Song KD, Kang TW, Kim YS, Lim HK. New Radiofrequency Device to Reduce Bleeding after Core Needle Biopsy: Experimental Study in a Porcine Liver Model. Korean J Radiol. 2017 Jan-Feb;18(1):173-179. doi: 10.3348/kjr.2017.18.1.173. Epub 2017 Jan 5.
PubMed 28096727Choi SH, Lee JM, Lee KH, Kim SH, Lee JY, Han JK, Choi BI. Postbiopsy splenic bleeding in a dog model: comparison of cauterization, embolization, and plugging of the needle tract. AJR Am J Roentgenol. 2005 Oct;185(4):878-84. doi: 10.2214/AJR.04.1395.
PubMed 16177404Song KD, Rhim H, Lee MW, Kang TW, Lim S. A radiofrequency device for tract ablation after liver biopsy: a single-institution human feasibility study. Br J Radiol. 2018 May;91(1085):20170585. doi: 10.1259/bjr.20170585. Epub 2018 Mar 8.
PubMed 29356562
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operator and Patient Acceptance of Radiofrequency Cautery of the Biopsy Track During Percutaneous Liver, Kidney or Spleen Biopsy Procedures.
- ClinicalTrials.gov ID
- NCT05790109
- Acronym / sponsor ID
- 2022P001476
- Conditions
- Bleeding Disorder, Spleen Lesion, Liver Diseases, Kidney Diseases
- Keywords
- Biopsy, Cautery, Bleeding, Liver, Kidney, Spleen, Hemostasis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: changed study design to retrospective study, since the study intervention is already in routine clinical practice
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 23 May 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Percutaneous biopsies of abdominal organs (liver, kidney, spleen) are commonly performed procedures and, while generally considered safe, have a small risk of post-biopsy hemorrhage. Bleeding risks of percutaneous biopsy are known to be higher for solid abdominal organs including liver, kidney and spleen, than for abdominal biopsies not involving these organs (for example, peritoneal masses or lymph nodes) Some patients also exhibit an increase in bleeding risk due to alterations in coagulation parameters or platelet number and function, which are known to increase rates of post-biopsy hemorrhage. Existing corrective measures for bleeding diathesis such as blood product transfusions are costly and confer additional risks, and do not address the mechanical tissue and vessel injury that sometimes underlies post-biopsy bleeding. Injection of gelatin sponge or other materials into the biopsy track via the introducer needle, while commonly used, can be cumbersome and imprecise, and has not yet clearly demonstrated a benefit in reducing post-biopsy bleeding in human studies.
High-frequency RF cautery, a technique ubiquitous in modern surgical practice, is routinely used for intraoperative hemostasis. This technique is also routinely used during image-guided percutaneous thermal ablation procedures, where the needle track created by the ablation probe is cauterized during probe retraction. An FDA-cleared bipolar RF cautery device that fits through a 17G biopsy introducer needle is now in clinical use, for the purpose of minimizing bleeding during percutaneous image-guided procedures. This study aims to prospectively study the physician and patient experience of using RF track cautery in patients undergoing percutaneous liver, kidney, or spleen biopsy procedures.
Primary aims of the study are:
- Determine how the use of radiofrequency (RF) track cautery during percutaneous solid organ biopsy affects operator experience.
- Determine how the use of radiofrequency (RF) track cautery during percutaneous solid organ biopsy affects patient experience.
Secondary aims of the study are:
- Determine the technical success rate of RF track cautery during percutaneous solid organ biopsy, defined by successful deployment of the cautery electrode through the biopsy introducer needle and application of radiofrequency current to the biopsy track.
- Monitor adverse events, such as bleeding, during and after biopsy procedures in which RF track cautery is used.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RF biopsy track cautery | Experimental | Device: RF track cautery during percutaneous organ biopsyThis study is designed as an open-label, single arm study, wherein all study participants will undergo RF track cautery during percutaneous liver, kidney, or spleen biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients referred to interventional radiology for clinically indicated liver, kidney, or spleen biopsy for diffuse or focal disease, who also have one or more of the following risk factors for bleeding:
- Coagulopathy (INR ≥ 1.5) or thrombocytopenia (platelets < 50) before correction
- Renal disease with glomerular filtration rate (GFR) < 30 ml/min
- Liver cirrhosis
- Anticoagulant or antiplatelet medications where periprocedural withholding poses
Key exclusion criteria (3 listed)
- Uncorrectable coagulopathy (INR remaining ≥ 2.5) or thrombocytopenia (platelets remaining < 25)
- Pregnancy
- Patients who are not competent to provide their own consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RF track cautery during percutaneous organ biopsyAfter 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. | Device | RF biopsy track cautery |
Primary outcome
Patient experience during use of radiofrequency track cautery during percutaneous organ biopsy
Time frame: Within 6 hours after procedure
Patient experience will be assessed via a questionnaire completed while in the recovery area following their procedure. The patient questionnaire will include questions regarding patient recollection of discomfort related to RF cautery, and whether or not they would be willing to have RF cautery performed again during a future biopsy session, if indicated.
Operator experience during use of radiofrequency track cautery during percutaneous organ biopsy
Time frame: Within 7 days after procedure
Operator experience will be assessed via a post-procedure questionnaire (included below) administered to all study operators immediately after they perform each biopsy procedure with RF cautery. The operator questionnaire will consist of a series of questions related to the use of RF cautery, focusing on factors such as ease of use, added procedure time, perceived benefits/detriments, and the operator's perception of associated patient discomfort.
2 secondary outcomes
Technical success rate of radiofrequency track cautery during percutaneous organ biopsy
Time frame: Within 7 days after procedure
Adverse events of radiofrequency track cautery during percutaneous organ biopsy
Time frame: Within 30 days after procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Background: PubMed 24281024Minami Y, Hayaishi S, Kudo M. Radiofrequency ablation for hepatic malignancies: is needle tract cauterization necessary for preventing iatrogenic bleeding? Dig Dis. 2013;31(5-6):480-4. doi: 10.1159/000355254. Epub 2013 Nov 21.
- Background: PubMed 12676970Laeseke PF, Winter TC 3rd, Davis CL, Stevens KR, Johnson CD, Fronczak FJ, Webster JG, Lee FT Jr. Postbiopsy bleeding in a porcine model: reduction with radio-frequency ablation--preliminary results. Radiology. 2003 May;227(2):493-9. doi: 10.1148/radiol.2272020173. Epub 2003 Apr 3.
- Background: PubMed 14963187Pritchard WF, Wray-Cahen D, Karanian JW, Hilbert S, Wood BJ. Radiofrequency cauterization with biopsy introducer needle. J Vasc Interv Radiol. 2004 Feb;15(2 Pt 1):183-7. doi: 10.1097/01.rvi.000019398.74740.69.
- Background: PubMed 28096727Lim S, Rhim H, Lee MW, Song KD, Kang TW, Kim YS, Lim HK. New Radiofrequency Device to Reduce Bleeding after Core Needle Biopsy: Experimental Study in a Porcine Liver Model. Korean J Radiol. 2017 Jan-Feb;18(1):173-179. doi: 10.3348/kjr.2017.18.1.173. Epub 2017 Jan 5.
- Background: PubMed 16177404Choi SH, Lee JM, Lee KH, Kim SH, Lee JY, Han JK, Choi BI. Postbiopsy splenic bleeding in a dog model: comparison of cauterization, embolization, and plugging of the needle tract. AJR Am J Roentgenol. 2005 Oct;185(4):878-84. doi: 10.2214/AJR.04.1395.
- Background: PubMed 29356562Song KD, Rhim H, Lee MW, Kang TW, Lim S. A radiofrequency device for tract ablation after liver biopsy: a single-institution human feasibility study. Br J Radiol. 2018 May;91(1085):20170585. doi: 10.1259/bjr.20170585. Epub 2018 Mar 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul B Shyn, M.D. principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RF track cautery during percutaneous organ biopsy in people with Bleeding Disorder and Spleen Lesion, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient experience during use of radiofrequency track cautery during percutaneous organ biopsy (time frame: Within 6 hours after procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05790109, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.