Pelvic AbscessUTACNCT06988280
Ultrasound-guided Transvaginal Aspiration of Cystic Pelvic Lesions
An observational study of Pelvic Abscess and Adnexal Cyst, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Adnexal cysts or pseudocysts are a common finding on transvaginal ultrasound, especially in premenopausal women. Due to the size of some cysts, they may cause discomfort. Moreover, a genuine risk of ovarian torsion presents when these lesions grow. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Abscess, Adnexal Cyst, Ovarian Neoplasms
- What is being tested?
- Ultrasound-guided transvaginal aspiration of cystic pelvic lesions.
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Mar 2025to Dec 2028
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients elligible based on the above mentioned criteria in University Hospitals Leuven.
Who may be able to join
None listed.
Who cannot join
- Patients <18 years
- Poor performance status contra-indicating the procedure
- Vaginal stenosis (severe atrophy - virgo - vaginismus)
- Purely solid lesions
- Cystic lesions with a presumed malignant diagnosis and a risk of tumor dissemination in a curative setting
- Physiological cysts in asymptomatic patients (in case of doubt the patient is reassessed after 3-6 months)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000
Stefan Timmerman, MD, +32 16 34 47 50, stefan.timmerman@uzleuven.be
Wouter Froyman, MD, PHD
About this study
Adnexal cysts or pseudocysts are a common finding on transvaginal ultrasound, especially in premenopausal women. Due to the size of some cysts, they may cause discomfort. Moreover, a genuine risk of ovarian torsion presents when these lesions grow.
During the last decades, great advancements have been made in the correct differentiation of benign from malignant lesions. However, there still is controversy concerning the optimal treatment approach of symptomatic adnexal cysts with a low risk of malignancy, consisting of both surgery or ultrasound-guided transvaginal aspiration. Factors such as comorbidities and lesion characteristics need to be considered when counselling patients, as well as the possibility of short term recurrence.
Read more
Surgically removing them may result in longer hospital stays and recovery, with higher costs, while transvaginal needle aspiration techniques can be performed during a consultation. Additional benefits in avoiding surgery, particularly in women of reproductive age, are fertility preservation and less pelvic adhesions.
On the other hand, the main arguments against cyst aspiration are the relatively high recurrence rate of cysts, the minimal risk of malignant cell dissemination (In case of a false negative diagnosis) and the cytological instead of a histopathological examination.
With this in mind, it is important to base management decisions on the sonographic features of the lesions.
In addition, cyst aspiration can also be considered in large symptomatic cysts with a high risk of malignancy, but where curative treatment with surgical or chemotherapeutical intervention cannot be considered due to poor general condition of the patient. Especially in the absence of large volume ascites or peritoneal carcinomatosis, but with significant symptoms due to lesion size, cyst aspiration may give short term symptom alleviation. Given the risk of cancer cell dissemination, this intervention is always discussed in a multidisciplinary team discussion, to balance risk and benefits for patients with no other treatment options, Transvaginal needle aspiration is also being used in pelvic abscesses. The study of K. Gjelland et al. found that transvaginal aspiration combined with antibiotic treatment of pelvic abscesses is equally effective as surgically removing them. They state that this should be first-line treatment for abscesses, as it is minimally invasive, leading to better patient tolerance and avoiding the risks associated with anesthesia and surgery.
Saline irrigation of the abscess cavity can be performed, making the process of pus aspiration easier when the consistency is too viscous.
The literature still lacks studies about the symptom relief in patients receiving treatment for pelvic cystic lesions. Given that this is an important outcome parameter in determining the feasibility of performing procedures, more research in this area is needed.
The main aim of this prospective study is to evaluate the patient's symptom relief and cyst recurrence rate after ultrasound-guided transvaginal aspiration of pelvic cystic lesions or abscess drainage. Secondly, the safety and the patient's overall experience during as well as immediately after the procedure will be assessed.
- Conditions
- Pelvic Abscess, Adnexal Cyst, Ovarian Neoplasms
- Being tested
- Ultrasound-guided transvaginal aspiration of cystic pelvic lesions.
- Keywords
- adnexal cyst, transvaginal aspiration, cyst recurrence, pelvic abscess, symptom relief
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided transvaginal aspiration of cystic pelvic lesions.Diagnostic test
Ultrasound-guided transvaginal aspiration is a minimally invasive procedure used to drain cystic pelvic lesions, such as adnexal cysts or pelvic abscesses. A thin needle is inserted through the vaginal wall under ultrasound guidance to aspirate fluid from the cyst, reducing its size.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pelvic cystic lesions (i.e adnexal lesions and abscesses) | Patients with cystic lesions (i.e adnexal lesions and abscesses), undergoing an ultrasound-guided transvaginal drainage as per our standard of practice. Receives: Diagnostic Test: Ultrasound-guided transvaginal aspiration of cystic pelvic lesions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on verbal rating scale (0-10)
Pain scores indicated by the patient prior to the procedure, during the procedure, one week after and three months after the procedure.
Measured: • Pain scores indicated by the patient prior to the procedure, during the procedure, one week after and three months after the procedure (based on a verbal rating scale).
Recurrence of cyst (binary outcome after 12 months)
Clinical and sonographic follow-up of possible recurrence (up till 12 months). Routine assessment will be done after 3 and 12 months
Measured: 12 months
Secondary outcomes (2)
General experience during the procedure (based on verbal rating scale 0-10)
General experience during the procedure based on verbal rating scale, assessed after the procedure by an independent examiner.
Measured: Right after the procedure to 3 days after.
Complications (based on Clavien Dindo classification)
Registration of adverse events, such as Vasovagal reaction, bleeding, infection, excessive pain.
Measured: Immediately after the procedure to 6 weeks after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start13 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pelvic AbscessStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988280
- Sponsor's protocol ID
- S68671
- Acronym
- UTAC
- Status last verified
- Mar 2025
- First submitted
- 15 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be added in the journal submission, and will be made available to other investigators on reasonable request.
Publications
Saokar A, Arellano RS, Gervais DA, Mueller PR, Hahn PF, Lee SI. Transvaginal drainage of pelvic fluid collections: results, expectations, and experience. AJR Am J Roentgenol. 2008 Nov;191(5):1352-8. doi: 10.2214/AJR.07.3808.
PubMed 18941068Feld R, Eschelman DJ, Sagerman JE, Segal S, Hovsepian DM, Sullivan KL. Treatment of pelvic abscesses and other fluid collections: efficacy of transvaginal sonographically guided aspiration and drainage. AJR Am J Roentgenol. 1994 Nov;163(5):1141-5. doi: 10.2214/ajr.163.5.7976890.
PubMed 7976890Caspi B, Goldchmit R, Zalel Y, Appelman Z, Insler V. Sonographically guided aspiration of ovarian cyst with simple appearance. J Ultrasound Med. 1996 Apr;15(4):297-300. doi: 10.7863/jum.1996.15.4.297.
PubMed 8683664Troiano RN, Taylor KJ. Sonographically guided therapeutic aspiration of benign-appearing ovarian cysts and endometriomas. AJR Am J Roentgenol. 1998 Dec;171(6):1601-5. doi: 10.2214/ajr.171.6.9843295.
PubMed 9843295Corsi PJ, Johnson SC, Gonik B, Hendrix SL, McNeeley SG Jr, Diamond MP. Transvaginal ultrasound-guided aspiration of pelvic abscesses. Infect Dis Obstet Gynecol. 1999;7(5):216-21. doi: 10.1002/(SICI)1098-0997(1999)7:53.0.CO;2-N.
PubMed 10524665Gjelland K, Ekerhovd E, Granberg S. Transvaginal ultrasound-guided aspiration for treatment of tubo-ovarian abscess: a study of 302 cases. Am J Obstet Gynecol. 2005 Oct;193(4):1323-30. doi: 10.1016/j.ajog.2005.06.019.
PubMed 16202721Urfali FE, Korkmaz M, Zeren S, Yaylak F, Tok Umay S. Percutaneous drainage as an rapid procedure for deep pelvic abscess in the emergency department. Ulus Travma Acil Cerrahi Derg. 2021 Sep;27(5):534-538. doi: 10.14744/tjtes.2020.99478.
PubMed 34476798Tsai CC, Shen CC, Changchien CC, Hsu TY, Kung FT, Chang SY, Chang MY, Huang FJ. Ultrasound-guided transvaginal cyst aspiration for the management of pelvic pseudocyst: a preliminary experience. Chang Gung Med J. 2002 Nov;25(11):751-7.
PubMed 12553363Timmerman D, Van Calster B, Testa A, Savelli L, Fischerova D, Froyman W, Wynants L, Van Holsbeke C, Epstein E, Franchi D, Kaijser J, Czekierdowski A, Guerriero S, Fruscio R, Leone FPG, Rossi A, Landolfo C, Vergote I, Bourne T, Valentin L. Predicting the risk of malignancy in adnexal masses based on the Simple Rules from the International Ovarian Tumor Analysis group. Am J Obstet Gynecol. 2016 Apr;214(4):424-437. doi: 10.1016/j.ajog.2016.01.007. Epub 2016 Jan 19.
PubMed 26800772Duke D, Colville J, Keeling A, Broe D, Fotheringham T, Lee MJ. Transvaginal aspiration of ovarian cysts: long-term follow-up. Cardiovasc Intervent Radiol. 2006 May-Jun;29(3):401-5. doi: 10.1007/s00270-005-0167-0.
PubMed 16502175Diaz de la Noval B, Rodriguez Suarez MJ, Fernandez Ferrera CB, Valdes Lafuente D, Arias Cailleau R, Perez Arias H, Torrejon Becerra JC, Suarez Gil P, Lucio Gonzalez LR. Transvaginal Ultrasound-Guided Fine-Needle Aspiration of Adnexal Cysts With a Low Risk of Malignancy: Our Experience and Recommendations. J Ultrasound Med. 2020 Sep;39(9):1787-1797. doi: 10.1002/jum.15283. Epub 2020 Apr 16.
PubMed 32298023Garcia-Tejedor A, Castellarnau M, Burdio F, Fernandez E, Marti D, Pla MJ, Ponce J. Ultrasound-guided aspiration of adnexal cysts with a low risk of malignancy: is it a recommendable option? J Ultrasound Med. 2015 Jun;34(6):985-91. doi: 10.7863/ultra.34.6.985.
PubMed 26014317Kostrzewa M, Zajac A, Wilczynski JR, Stachowiak G. Retrospective analysis of transvaginal ultrasound-guided aspiration of simple ovarian cysts. Adv Clin Exp Med. 2019 Nov;28(11):1531-1535. doi: 10.17219/acem/104549.
PubMed 31660708
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Transvaginal Aspiration of Cystic Pelvic Lesions
- ClinicalTrials.gov ID
- NCT06988280
- Acronym / sponsor ID
- UTAC / S68671
- Conditions
- Pelvic Abscess, Adnexal Cyst, Ovarian Neoplasms
- Keywords
- adnexal cyst, transvaginal aspiration, cyst recurrence, pelvic abscess, symptom relief
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 May 2025 (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.
Adnexal cysts or pseudocysts are a common finding on transvaginal ultrasound, especially in premenopausal women. Due to the size of some cysts, they may cause discomfort. Moreover, a genuine risk of ovarian torsion presents when these lesions grow.
During the last decades, great advancements have been made in the correct differentiation of benign from malignant lesions. However, there still is controversy concerning the optimal treatment approach of symptomatic adnexal cysts with a low risk of malignancy, consisting of both surgery or ultrasound-guided transvaginal aspiration. Factors such as comorbidities and lesion characteristics need to be considered when counselling patients, as well as the possibility of short term recurrence.
Surgically removing them may result in longer hospital stays and recovery, with higher costs, while transvaginal needle aspiration techniques can be performed during a consultation. Additional benefits in avoiding surgery, particularly in women of reproductive age, are fertility preservation and less pelvic adhesions.
On the other hand, the main arguments against cyst aspiration are the relatively high recurrence rate of cysts, the minimal risk of malignant cell dissemination (In case of a false negative diagnosis) and the cytological instead of a histopathological examination.
With this in mind, it is important to base management decisions on the sonographic features of the lesions.
In addition, cyst aspiration can also be considered in large symptomatic cysts with a high risk of malignancy, but where curative treatment with surgical or chemotherapeutical intervention cannot be considered due to poor general condition of the patient. Especially in the absence of large volume ascites or peritoneal carcinomatosis, but with significant symptoms due to lesion size, cyst aspiration may give short term symptom alleviation. Given the risk of cancer cell dissemination, this intervention is always discussed in a multidisciplinary team discussion, to balance risk and benefits for patients with no other treatment options, Transvaginal needle aspiration is also being used in pelvic abscesses. The study of K. Gjelland et al. found that transvaginal aspiration combined with antibiotic treatment of pelvic abscesses is equally effective as surgically removing them. They state that this should be first-line treatment for abscesses, as it is minimally invasive, leading to better patient tolerance and avoiding the risks associated with anesthesia and surgery.
Saline irrigation of the abscess cavity can be performed, making the process of pus aspiration easier when the consistency is too viscous.
The literature still lacks studies about the symptom relief in patients receiving treatment for pelvic cystic lesions. Given that this is an important outcome parameter in determining the feasibility of performing procedures, more research in this area is needed.
The main aim of this prospective study is to evaluate the patient's symptom relief and cyst recurrence rate after ultrasound-guided transvaginal aspiration of pelvic cystic lesions or abscess drainage. Secondly, the safety and the patient's overall experience during as well as immediately after the procedure will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pelvic cystic lesions (i.e adnexal lesions and abscesses) | – | Diagnostic Test: Ultrasound-guided transvaginal aspiration of cystic pelvic lesions.Patients with cystic lesions (i.e adnexal lesions and abscesses), undergoing an ultrasound-guided transvaginal drainage as per our standard of practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients elligible based on the above mentioned criteria in University Hospitals Leuven.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Patients <18 years
- Poor performance status contra-indicating the procedure
- Vaginal stenosis (severe atrophy - virgo - vaginismus)
- Purely solid lesions
- Cystic lesions with a presumed malignant diagnosis and a risk of tumor dissemination in a curative setting
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 |
|---|---|---|
| Ultrasound-guided transvaginal aspiration of cystic pelvic lesions.Ultrasound-guided transvaginal aspiration is a minimally invasive procedure used to drain cystic pelvic lesions, such as adnexal cysts or pelvic abscesses. A thin needle is inserted through the vaginal wall under ultrasound guidance to aspirate fluid from the cyst, reducing its size. | Diagnostic test | Patients with pelvic cystic lesions (i.e adnexal lesions and abscesses) |
Primary outcome
Pain on verbal rating scale (0-10)
Time frame: • Pain scores indicated by the patient prior to the procedure, during the procedure, one week after and three months after the procedure (based on a verbal rating scale).
Pain scores indicated by the patient prior to the procedure, during the procedure, one week after and three months after the procedure.
Recurrence of cyst (binary outcome after 12 months)
Time frame: 12 months
Clinical and sonographic follow-up of possible recurrence (up till 12 months). Routine assessment will be done after 3 and 12 months
2 secondary outcomes
General experience during the procedure (based on verbal rating scale 0-10)
Time frame: Right after the procedure to 3 days after.
Complications (based on Clavien Dindo classification)
Time frame: Immediately after the procedure to 6 weeks after the procedure.
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 23 May 2025.
- Background: PubMed 18941068Saokar A, Arellano RS, Gervais DA, Mueller PR, Hahn PF, Lee SI. Transvaginal drainage of pelvic fluid collections: results, expectations, and experience. AJR Am J Roentgenol. 2008 Nov;191(5):1352-8. doi: 10.2214/AJR.07.3808.
- Background: PubMed 7976890Feld R, Eschelman DJ, Sagerman JE, Segal S, Hovsepian DM, Sullivan KL. Treatment of pelvic abscesses and other fluid collections: efficacy of transvaginal sonographically guided aspiration and drainage. AJR Am J Roentgenol. 1994 Nov;163(5):1141-5. doi: 10.2214/ajr.163.5.7976890.
- Background: PubMed 8683664Caspi B, Goldchmit R, Zalel Y, Appelman Z, Insler V. Sonographically guided aspiration of ovarian cyst with simple appearance. J Ultrasound Med. 1996 Apr;15(4):297-300. doi: 10.7863/jum.1996.15.4.297.
- Background: PubMed 9843295Troiano RN, Taylor KJ. Sonographically guided therapeutic aspiration of benign-appearing ovarian cysts and endometriomas. AJR Am J Roentgenol. 1998 Dec;171(6):1601-5. doi: 10.2214/ajr.171.6.9843295.
- Background: PubMed 10524665Corsi PJ, Johnson SC, Gonik B, Hendrix SL, McNeeley SG Jr, Diamond MP. Transvaginal ultrasound-guided aspiration of pelvic abscesses. Infect Dis Obstet Gynecol. 1999;7(5):216-21. doi: 10.1002/(SICI)1098-0997(1999)7:53.0.CO;2-N.
- Background: PubMed 16202721Gjelland K, Ekerhovd E, Granberg S. Transvaginal ultrasound-guided aspiration for treatment of tubo-ovarian abscess: a study of 302 cases. Am J Obstet Gynecol. 2005 Oct;193(4):1323-30. doi: 10.1016/j.ajog.2005.06.019.
- Background: PubMed 34476798Urfali FE, Korkmaz M, Zeren S, Yaylak F, Tok Umay S. Percutaneous drainage as an rapid procedure for deep pelvic abscess in the emergency department. Ulus Travma Acil Cerrahi Derg. 2021 Sep;27(5):534-538. doi: 10.14744/tjtes.2020.99478.
- Background: PubMed 12553363Tsai CC, Shen CC, Changchien CC, Hsu TY, Kung FT, Chang SY, Chang MY, Huang FJ. Ultrasound-guided transvaginal cyst aspiration for the management of pelvic pseudocyst: a preliminary experience. Chang Gung Med J. 2002 Nov;25(11):751-7.
- Background: PubMed 26800772Timmerman D, Van Calster B, Testa A, Savelli L, Fischerova D, Froyman W, Wynants L, Van Holsbeke C, Epstein E, Franchi D, Kaijser J, Czekierdowski A, Guerriero S, Fruscio R, Leone FPG, Rossi A, Landolfo C, Vergote I, Bourne T, Valentin L. Predicting the risk of malignancy in adnexal masses based on the Simple Rules from the International Ovarian Tumor Analysis group. Am J Obstet Gynecol. 2016 Apr;214(4):424-437. doi: 10.1016/j.ajog.2016.01.007. Epub 2016 Jan 19.
- Background: PubMed 16502175Duke D, Colville J, Keeling A, Broe D, Fotheringham T, Lee MJ. Transvaginal aspiration of ovarian cysts: long-term follow-up. Cardiovasc Intervent Radiol. 2006 May-Jun;29(3):401-5. doi: 10.1007/s00270-005-0167-0.
- Background: PubMed 32298023Diaz de la Noval B, Rodriguez Suarez MJ, Fernandez Ferrera CB, Valdes Lafuente D, Arias Cailleau R, Perez Arias H, Torrejon Becerra JC, Suarez Gil P, Lucio Gonzalez LR. Transvaginal Ultrasound-Guided Fine-Needle Aspiration of Adnexal Cysts With a Low Risk of Malignancy: Our Experience and Recommendations. J Ultrasound Med. 2020 Sep;39(9):1787-1797. doi: 10.1002/jum.15283. Epub 2020 Apr 16.
- Background: PubMed 26014317Garcia-Tejedor A, Castellarnau M, Burdio F, Fernandez E, Marti D, Pla MJ, Ponce J. Ultrasound-guided aspiration of adnexal cysts with a low risk of malignancy: is it a recommendable option? J Ultrasound Med. 2015 Jun;34(6):985-91. doi: 10.7863/ultra.34.6.985.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be added in the journal submission, and will be made available to other investigators on reasonable request.
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.
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 Pelvic Abscess and Adnexal Cyst, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 0 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 May 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 Belgium. 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 Stefan Timmerman, MD (+32 16 34 47 50, stefan.timmerman@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on verbal rating scale (0-10) (time frame: • Pain scores indicated by the patient prior to the procedure, during the procedure, one week after and three months after the procedure (based on a verbal rating scale).). 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 NCT06988280, which also lists 13 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 23 May 2025.