Malignancy-induced Pelvic PainNCT06110065
CT-guided Pudendal Nerve Cryoneurolysis for Palliation of Malignancy-induced Pelvic Pain
An observational study of Malignancy-induced Pelvic Pain, run by University of Arizona at 1 site in United States.
Trial summary
We want to study if a new treatment called "CT-guided bilateral pudendal nerve cryoneurolysis" can help people with severe and long-lasting pain in the pelvic area caused by cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancy-induced Pelvic Pain
- What is being tested?
- CT-guided Pudendal Nerve Cryoneurolysis and Percutaneous image-guided cryoneurolysis
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2023to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Interventional Radiology Oncology clinic
Who may be able to join
- Those already scheduled for a CT-guided bilateral pudendal nerve cryoneurolysis as standard of care Age ≥18 years old Active or history of pelvic cancer malignancy Poor pelvic pain control with current therapy (pain from cancer malignancy) Pain in distribution of the pudendal (genital) nerves from cancer malignancy
Who cannot join
- Pain in distribution of the pudendal nerves from nonmalignant etiology Patients with pain from other medical conditions besides cancer/cancer malignancy will not be included (cancer-related pain from cancer malignancy in the genital region is considered).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
We want to study if a new treatment called "CT-guided bilateral pudendal nerve cryoneurolysis" can help people with severe and long-lasting pain in the pelvic area caused by cancer. We will closely follow and observe patients who undergo this treatment to see if it works well, what results it gives, and if there are any problems or side effects. "Percutaneous image-guided cryoneurolysis" involves using very cold temperatures to treat the nerves causing the pain. This method has been found to provide longer pain relief compared to injections or catheters, and it also has a lower risk of certain complications.
We are conducting a study to assess the effectiveness of two different treatments for severe and persistent pelvic pain caused by cancer. The first treatment, known as "CT-guided bilateral pudendal nerve cryoneurolysis," involves using advanced imaging technology to precisely target and freeze the pudendal nerves, which are responsible for transmitting pain signals. By closely monitoring patients who receive this treatment, we aim to evaluate its efficacy, outcomes, and potential side effects.
Read more
On the other hand, the second treatment approach, referred to as "Percutaneous image-guided cryoneurolysis," focuses on using extremely cold temperatures to alleviate pain originating from the pudendal nerves. This method has demonstrated extended pain relief compared to alternatives like injections or catheters. Additionally, it presents a lower risk of certain complications. Through our study, we seek to gain insights into the effectiveness and safety of both treatment methods, enhancing our understanding of how to address the challenging issue of cancer-related pelvic pain.
The study will enroll patients who are dealing with severe and persistent pelvic pain from cancer. All patients will undergo the CT-guided bilateral pudendal nerve cryoneurolysis first type of treatment and if it is not effective in relieving the pain, they will be offered to undergo the second treatment called Percutaneous image-guided cryoneurolysis.
Both of these treatments are done as standard of care. This research study will not alter standard of care. Subjects will only be enrolled into this study if they are already undergoing CT-guided bilateral pudendal nerve cryoneurolysis followed up with Percutaneous image-guided cryoneurolysis, as needed. This is a prospective study of these two treatments following patient outcomes.
- Conditions
- Malignancy-induced Pelvic Pain
- Being tested
- CT-guided Pudendal Nerve Cryoneurolysis, Percutaneous image-guided cryoneurolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided Pudendal Nerve CryoneurolysisDrug
CT-guided bilateral pudendal nerve cryoneurolysis involves using advanced imaging technology to precisely target and freeze the pudendal nerves, which are responsible for transmitting pain signals.
Percutaneous image-guided cryoneurolysisDrug
Percutaneous image-guided cryoneurolysis focuses on using extremely cold temperatures to alleviate pain originating from the pudendal nerves. This method has demonstrated extended pain relief compared to alternatives like injections or catheters. Additionally, it presents a lower risk of certain complications.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Not described Receives: Drug: CT-guided Pudendal Nerve Cryoneurolysis; Drug: Percutaneous image-guided cryoneurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Improvement
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignancy-induced Pelvic PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shamar J Young, MD, Principal investigator, University of Arizona - Department of Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110065
- Sponsor's protocol ID
- STUDY00002955
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-guided Pudendal Nerve Cryoneurolysis for Palliation of Malignancy-induced Pelvic Pain
- ClinicalTrials.gov ID
- NCT06110065
- Acronym / sponsor ID
- STUDY00002955
- Conditions
- Malignancy-induced Pelvic Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 31 Oct 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.
We want to study if a new treatment called "CT-guided bilateral pudendal nerve cryoneurolysis" can help people with severe and long-lasting pain in the pelvic area caused by cancer. We will closely follow and observe patients who undergo this treatment to see if it works well, what results it gives, and if there are any problems or side effects. "Percutaneous image-guided cryoneurolysis" involves using very cold temperatures to treat the nerves causing the pain. This method has been found to provide longer pain relief compared to injections or catheters, and it also has a lower risk of certain complications.
We are conducting a study to assess the effectiveness of two different treatments for severe and persistent pelvic pain caused by cancer. The first treatment, known as "CT-guided bilateral pudendal nerve cryoneurolysis," involves using advanced imaging technology to precisely target and freeze the pudendal nerves, which are responsible for transmitting pain signals. By closely monitoring patients who receive this treatment, we aim to evaluate its efficacy, outcomes, and potential side effects.
On the other hand, the second treatment approach, referred to as "Percutaneous image-guided cryoneurolysis," focuses on using extremely cold temperatures to alleviate pain originating from the pudendal nerves. This method has demonstrated extended pain relief compared to alternatives like injections or catheters. Additionally, it presents a lower risk of certain complications. Through our study, we seek to gain insights into the effectiveness and safety of both treatment methods, enhancing our understanding of how to address the challenging issue of cancer-related pelvic pain.
The study will enroll patients who are dealing with severe and persistent pelvic pain from cancer. All patients will undergo the CT-guided bilateral pudendal nerve cryoneurolysis first type of treatment and if it is not effective in relieving the pain, they will be offered to undergo the second treatment called Percutaneous image-guided cryoneurolysis.
Both of these treatments are done as standard of care. This research study will not alter standard of care. Subjects will only be enrolled into this study if they are already undergoing CT-guided bilateral pudendal nerve cryoneurolysis followed up with Percutaneous image-guided cryoneurolysis, as needed. This is a prospective study of these two treatments following patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: CT-guided Pudendal Nerve Cryoneurolysis, Drug: Percutaneous image-guided cryoneurolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Interventional Radiology Oncology clinic
Key inclusion criteria (1 listed)
- Those already scheduled for a CT-guided bilateral pudendal nerve cryoneurolysis as standard of care Age ≥18 years old Active or history of pelvic cancer malignancy Poor pelvic pain control with current therapy (pain from cancer malignancy) Pain in distribution of the pudendal (genital) nerves from cancer malignancy
Key exclusion criteria (1 listed)
- Pain in distribution of the pudendal nerves from nonmalignant etiology Patients with pain from other medical conditions besides cancer/cancer malignancy will not be included (cancer-related pain from cancer malignancy in the genital region is considered).
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 |
|---|---|---|
| CT-guided Pudendal Nerve CryoneurolysisCT-guided bilateral pudendal nerve cryoneurolysis involves using advanced imaging technology to precisely target and freeze the pudendal nerves, which are responsible for transmitting pain signals. | Drug | Cohort 1 |
| Percutaneous image-guided cryoneurolysisPercutaneous image-guided cryoneurolysis focuses on using extremely cold temperatures to alleviate pain originating from the pudendal nerves. This method has demonstrated extended pain relief compared to alternatives like injections or catheters. Additionally, it presents a lower risk of certain complications. | Drug | Cohort 1 |
Primary outcome
Visual Analog Scale (VAS) Improvement
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
Related trials for Malignancy-induced Pelvic Pain
RecruitingObservational study
Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment
Chronic Pelvic Pain Syndrome (CPPS), Radiation-Induced Disorder
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.
Shamar J Young, MD principal investigator
University of Arizona - Department of Medical Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignancy-induced Pelvic Pain, run by University of Arizona 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 31 Oct 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shamar J Young, MD (5206261957, shamar@radiology.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Improvement (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2023.