Breast CancerESCALNCT06910280
Evaluation of the Feasibility of a Study Comparing Local Anesthesia and General Anesthesia in Conservative Surgery for Breast Cancer
A study testing conservative surgery for breast cancer with local anesthesia and conservative surgery for breast cancer with general anesthesia in people with Breast Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The conservative surgery for breast cancer is the first treatment for cancer and includes : A partial mastectomy (removal of part of the breast) A sentinel lymph node analysis, depending on the case (analysis of the first lymph node(s) draining the affected breast). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- conservative surgery for breast cancer with local anesthesia and conservative surgery for breast cancer with general anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- May 2025to Nov 2026
- Phase
- Interventional
- 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
Who may be able to join
- Female over 18 years of age
- Diagnosis of invasive breast cancer (histological proof via breast biopsy)
- Tumor size less than or equal to clinical T2 according to the current cTNM classification for breast cancer"
- No clinical and/or radiological evidence of lymph node involvement
- Affiliation to a French social security scheme or beneficiary of such a scheme
- Approval in the multidisciplinary tumor board meeting for conservative treatment with partial mastectomy combined with sentinel lymph node biopsy
- Signed informed consent indicating that the patient understands the purpose and procedures required by the study and agrees to participate in the study and comply with its requirements and restrictions
Who cannot join
- Severe and morbid obesity (BMI strictly greater than 35)
- Emaciation (BMI strictly less than 18.5)
- Contraindication to the medications used in the protocol
- Contraindication to general anesthesia
- Contraindication to the local anesthesia protocol
- Tumor considered non-resectable under local anesthesia according to the surgeon's assessment
Show all 15Show fewer
- Bifocal tumor
- Associated oncoplastic procedure
- Contralateral surgical procedure (implantable port placement, mastopexy, partial or total mastectomy)
- Withdrawal of consent prior to surgery
- Legal incapacity or limited legal capacity
- Non-fluency in the French language or poor understanding as anticipated by the investigator
- Subject without health insurance
- Pregnant woman
- Subject currently in the exclusion period of another study or listed in the national volunteer registry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Besancon
Besançon, Franche Comte, 25000
PIERRE BEDAT, +330381218113, bedatpi@gmail.com
PIERRE BEDAT
About this study
The conservative surgery for breast cancer is the first treatment for cancer and includes :
- A partial mastectomy (removal of part of the breast)
- A sentinel lymph node analysis, depending on the case (analysis of the first lymph node(s) draining the affected breast).
Read more
This is a common procedure in the gynecology operating room, usually performed under general anesthesia. However, with surgical advancements and less invasive procedures, it has become possible and common for patients to undergo surgery in our department under local anesthesia. No data in the medical literature has yet evaluated this new anesthetic approach.
Through this study, we aim to assess the feasibility and acceptability of partial mastectomy surgery with sentinel lymph node removal under either local anesthesia or general anesthesia.
The ultimate goal of this study is to allow future patients to benefit from faster outpatient surgery, requiring less hospital stay, and to continue the progress of minimizing surgical interventions that has already been successfully undertaken in breast cancer treatment.
This is an interventional study because it involves randomization, which determines for each enrolled patient whether they will receive general anesthesia or local anesthesia. It is a feasibility and acceptability study
It is important to note that the surgery itself will not differ between the two groups: only the method of anesthesia will change. This research is being conducted at the University Hospital of Besançon and only at this center.
- Conditions
- Breast Cancer
- Being tested
- conservative surgery for breast cancer with local anesthesia, conservative surgery for breast cancer with general anesthesia
- Keywords
- breast cancer, conservative surgery, local anesthesia, quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conservative surgery for breast cancer with local anesthesiaProcedure or surgery
conservative surgery for breast cancer with local anesthesia
conservative surgery for breast cancer with general anesthesiaProcedure or surgery
conservative surgery for breast cancer with general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| With local anesthesia | Experimental | local anesthesia Receives: Procedure: conservative surgery for breast cancer with local anesthesia |
| With general anesthesia | Active comparator | general anesthesia Receives: Procedure: conservative surgery for breast cancer with general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Recruitment capacity : number of women per month meeting the inclusion criteria
Measured: 2 years
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Acceptability : proportion of patients who accepted inclusion in the study among those to whom it was proposed
Measured: 2 years
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Adherence : proportion of women included in the study who do not withdraw their consent before the start of surgery
Measured: 2 years
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Completeness : proportion of questionnaires completed at each time point of the study
Measured: 3 months
Secondary outcomes (4)
Describe the effectiveness and success of conservative surgery, including partial mastectomy combined with sentinel lymph node biopsy under non-tumescent local anesthesia without sedation in breast cancer
Proportion of surgical procedures in which the entire operative procedure could be performed under local anesthesia without the need for general anesthesia.
Measured: 3 months
Quantify postoperative pain in both arms of the study
Numerical rating scale for pain assessment 2 hours after leaving the operating room, 24 hours after discharge from the hospital, and 15 days after the procedure. Numerical rating scale for pain assessment and DN2 score at 3 months post-procedure.
Measured: 15 days
Quantify postoperative satisfaction and well-being in both arms of the study.
BREAST-Q - Breast Conserving Therapy Module
Subscales of the BREAST-Q:
Scale 6: Physical well-being: breast (preoperative) Scale 7: Physical well-being: breast (postoperative)
Measured: 3 months
Describe the oncological, anesthetic, and surgical safety of the surgical procedure in both arms of the study.
Need for reoperation of the breast (margins considered positive in case of 'at ink' involvement [tumor in contact with the ink] for the infiltrative component and possibly associated in situ component) Need for reoperation of the axillary region Allergic reactions Other side effects related to general or local anesthesia Postoperative surgical complications (hematoma, abscess, wound dehiscence) Length of hospital stay Death
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910280
- Sponsor's protocol ID
- 2024/927
- Acronym
- ESCAL
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seror J, Hequet D, Gout-Duracher C, Cittanova M laure. Faisabilité et impact de la chirurgie mammaire conservatrice sous anesthésie locale. Communication orale, Congrè SFSPM; 2022.
Karanlik H, Kilic B, Yildirim I, Bademler S, Ozgur I, Ilhan B, Onder S. Breast-Conserving Surgery Under Local Anesthesia in Elderly Patients with Severe Cardiorespiratory Comorbidities: A Hospital-Based Case-Control Study. Breast Care (Basel). 2017 Mar;12(1):29-33. doi: 10.1159/000455003. Epub 2017 Feb 8.
PubMed 28611538Hirokawa T, Kinoshita T, Nagao T, Hojo T. A clinical trial of curative surgery under local anesthesia for early breast cancer. Breast J. 2012 Mar-Apr;18(2):195-7. doi: 10.1111/j.1524-4741.2011.01221.x. Epub 2012 Feb 2. No abstract available.
PubMed 22300192Carlson GW. Total mastectomy under local anesthesia: the tumescent technique. Breast J. 2005 Mar-Apr;11(2):100-2. doi: 10.1111/j.1075-122X.2005.21536.x.
PubMed 15730454Sleth JC, Lavie M, Mion P, Saizy C, Servais R. [Tumescent local anaesthesia for mastectomy: lidocaine plasma concentration]. Ann Fr Anesth Reanim. 2006 Jan;25(1):74-6. doi: 10.1016/j.annfar.2005.07.074. Epub 2005 Oct 26. No abstract available. French.
PubMed 16256296Saint-Roch P. L'anesthésie locale tumescente a-t-elle une place ? 2013;
Anne-Pauline Cungi. Étude Hypno-Séno : anesthésie générale versus hypno-tumescence en chirurgie mammaire conservatrice : évaluation de la qualité des marges de résection chirurgicale. 2020;
Sleth JC, Servais R, Saizy C. [Tumescent infiltrative anaesthesia for mastectomy: about six cases]. Ann Fr Anesth Reanim. 2008 Nov;27(11):941-4. doi: 10.1016/j.annfar.2008.08.011. Epub 2008 Nov 11. French.
PubMed 19004607Ceccarino R, Di Micco R, Cappelletti R. Aesthetic Breast Surgery Under Cold Tumescent Anesthesia: Feasibility and Safety in Outpatient Clinic. Ann Plast Surg. 2019 Oct;83(4):384-387. doi: 10.1097/SAP.0000000000001798.
PubMed 31524728Boeer B, Helms G, Pasternak J, Roehm C, Kofler L, Haefner HM, Moehrle M, Heim E, Fischer H, Brucker SY, Hahn M. Back to the future: breast surgery with tumescent local anesthesia (TLA)? Arch Gynecol Obstet. 2023 Sep;308(3):935-940. doi: 10.1007/s00404-023-06938-5. Epub 2023 Mar 6.
PubMed 36872392Groetelaers RP, van Berlo CL, Nijhuis PH, Schapers RF, Gerritsen HA. Axillary recurrences after negative sentinel lymph node biopsy under local anaesthesia for breast cancer: a follow-up study after 5 years. Eur J Surg Oncol. 2009 Feb;35(2):159-63. doi: 10.1016/j.ejso.2008.07.017. Epub 2008 Sep 11.
PubMed 18789841van Berlo CL, Hess DA, Nijhuis PA, Leys E, Gerritsen HA, Schapers RF. Ambulatory sentinel node biopsy under local anaesthesia for patients with early breast cancer. Eur J Surg Oncol. 2003 May;29(4):383-5. doi: 10.1053/ejso.2002.1420.
PubMed 12711294Luini A, Gatti G, Frasson A, Naninato P, Magalotti C, Arnone P, Viale G, Pruneri G, Galimberti V, De Cicco C, Veronesi U. Sentinel lymph node biopsy performed with local anesthesia in patients with early-stage breast carcinoma. Arch Surg. 2002 Oct;137(10):1157-60. doi: 10.1001/archsurg.137.10.1157.
PubMed 12361425Luini A, Caldarella P, Gatti G, Veronesi P, Vento AR, Naninato P, Arnone P, Sangalli C, Brenelli F, Sosnovskikh I, Peradze N, Dussan Luberth CA, Viale G, Paganelli G. The sentinel node biopsy under local anesthesia in breast cancer: advantages and problems, how the technique influenced the activity of a breast surgery department; update from the European Institute of Oncology with more than 1000 cases. Breast. 2007 Oct;16(5):527-32. doi: 10.1016/j.breast.2007.04.003.
PubMed 17916496Luini A, Gatti G, Zurrida S, Galimberti V, Paganelli G, Naninato P, Caldarella P, Rotmensz N, Winnikow E, Viale G. The sentinel lymph node biopsy under local anesthesia in breast carcinoma: experience of the European Institute of Oncology and impact on quality of life. Breast Cancer Res Treat. 2005 Jan;89(1):69-74. doi: 10.1007/s10549-004-1473-y.
PubMed 15666199
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility of a Study Comparing Local Anesthesia and General Anesthesia in Conservative Surgery for Breast Cancer
- ClinicalTrials.gov ID
- NCT06910280
- Acronym / sponsor ID
- ESCAL / 2024/927
- Conditions
- Breast Cancer
- Keywords
- breast cancer, conservative surgery, local anesthesia, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 4 Apr 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.
The conservative surgery for breast cancer is the first treatment for cancer and includes :
- A partial mastectomy (removal of part of the breast)
- A sentinel lymph node analysis, depending on the case (analysis of the first lymph node(s) draining the affected breast).
This is a common procedure in the gynecology operating room, usually performed under general anesthesia. However, with surgical advancements and less invasive procedures, it has become possible and common for patients to undergo surgery in our department under local anesthesia. No data in the medical literature has yet evaluated this new anesthetic approach.
Through this study, we aim to assess the feasibility and acceptability of partial mastectomy surgery with sentinel lymph node removal under either local anesthesia or general anesthesia.
The ultimate goal of this study is to allow future patients to benefit from faster outpatient surgery, requiring less hospital stay, and to continue the progress of minimizing surgical interventions that has already been successfully undertaken in breast cancer treatment.
This is an interventional study because it involves randomization, which determines for each enrolled patient whether they will receive general anesthesia or local anesthesia. It is a feasibility and acceptability study
It is important to note that the surgery itself will not differ between the two groups: only the method of anesthesia will change. This research is being conducted at the University Hospital of Besançon and only at this center.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With local anesthesia | Experimental | Procedure: conservative surgery for breast cancer with local anesthesialocal anesthesia |
| With general anesthesia | Active comparator | Procedure: conservative surgery for breast cancer with general anesthesiageneral anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female over 18 years of age
- Diagnosis of invasive breast cancer (histological proof via breast biopsy)
- Tumor size less than or equal to clinical T2 according to the current cTNM classification for breast cancer"
- No clinical and/or radiological evidence of lymph node involvement
- Affiliation to a French social security scheme or beneficiary of such a scheme
Key exclusion criteria (15 listed)
- Severe and morbid obesity (BMI strictly greater than 35)
- Emaciation (BMI strictly less than 18.5)
- Contraindication to the medications used in the protocol
- Contraindication to general anesthesia
- Contraindication to the local anesthesia protocol
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 |
|---|---|---|
| conservative surgery for breast cancer with local anesthesiaconservative surgery for breast cancer with local anesthesia | Procedure or surgery | With local anesthesia |
| conservative surgery for breast cancer with general anesthesiaconservative surgery for breast cancer with general anesthesia | Procedure or surgery | With general anesthesia |
Primary outcome
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Time frame: 2 years
Recruitment capacity : number of women per month meeting the inclusion criteria
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Time frame: 2 years
Acceptability : proportion of patients who accepted inclusion in the study among those to whom it was proposed
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Time frame: 2 years
Adherence : proportion of women included in the study who do not withdraw their consent before the start of surgery
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Time frame: 3 months
Completeness : proportion of questionnaires completed at each time point of the study
4 secondary outcomes
Describe the effectiveness and success of conservative surgery, including partial mastectomy combined with sentinel lymph node biopsy under non-tumescent local anesthesia without sedation in breast cancer
Time frame: 3 months
Quantify postoperative pain in both arms of the study
Time frame: 15 days
Quantify postoperative satisfaction and well-being in both arms of the study.
Time frame: 3 months
Describe the oncological, anesthetic, and surgical safety of the surgical procedure in both arms of the study.
Time frame: 3 months
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 4 Apr 2025.
- BackgroundSeror J, Hequet D, Gout-Duracher C, Cittanova M laure. Faisabilité et impact de la chirurgie mammaire conservatrice sous anesthésie locale. Communication orale, Congrè SFSPM; 2022.
- Background: PubMed 28611538Karanlik H, Kilic B, Yildirim I, Bademler S, Ozgur I, Ilhan B, Onder S. Breast-Conserving Surgery Under Local Anesthesia in Elderly Patients with Severe Cardiorespiratory Comorbidities: A Hospital-Based Case-Control Study. Breast Care (Basel). 2017 Mar;12(1):29-33. doi: 10.1159/000455003. Epub 2017 Feb 8.
- Background: PubMed 22300192Hirokawa T, Kinoshita T, Nagao T, Hojo T. A clinical trial of curative surgery under local anesthesia for early breast cancer. Breast J. 2012 Mar-Apr;18(2):195-7. doi: 10.1111/j.1524-4741.2011.01221.x. Epub 2012 Feb 2. No abstract available.
- Background: PubMed 15730454Carlson GW. Total mastectomy under local anesthesia: the tumescent technique. Breast J. 2005 Mar-Apr;11(2):100-2. doi: 10.1111/j.1075-122X.2005.21536.x.
- Background: PubMed 16256296Sleth JC, Lavie M, Mion P, Saizy C, Servais R. [Tumescent local anaesthesia for mastectomy: lidocaine plasma concentration]. Ann Fr Anesth Reanim. 2006 Jan;25(1):74-6. doi: 10.1016/j.annfar.2005.07.074. Epub 2005 Oct 26. No abstract available. French.
- BackgroundSaint-Roch P. L'anesthésie locale tumescente a-t-elle une place ? 2013;
- BackgroundAnne-Pauline Cungi. Étude Hypno-Séno : anesthésie générale versus hypno-tumescence en chirurgie mammaire conservatrice : évaluation de la qualité des marges de résection chirurgicale. 2020;
- Background: PubMed 19004607Sleth JC, Servais R, Saizy C. [Tumescent infiltrative anaesthesia for mastectomy: about six cases]. Ann Fr Anesth Reanim. 2008 Nov;27(11):941-4. doi: 10.1016/j.annfar.2008.08.011. Epub 2008 Nov 11. French.
- Background: PubMed 31524728Ceccarino R, Di Micco R, Cappelletti R. Aesthetic Breast Surgery Under Cold Tumescent Anesthesia: Feasibility and Safety in Outpatient Clinic. Ann Plast Surg. 2019 Oct;83(4):384-387. doi: 10.1097/SAP.0000000000001798.
- Background: PubMed 36872392Boeer B, Helms G, Pasternak J, Roehm C, Kofler L, Haefner HM, Moehrle M, Heim E, Fischer H, Brucker SY, Hahn M. Back to the future: breast surgery with tumescent local anesthesia (TLA)? Arch Gynecol Obstet. 2023 Sep;308(3):935-940. doi: 10.1007/s00404-023-06938-5. Epub 2023 Mar 6.
- Background: PubMed 18789841Groetelaers RP, van Berlo CL, Nijhuis PH, Schapers RF, Gerritsen HA. Axillary recurrences after negative sentinel lymph node biopsy under local anaesthesia for breast cancer: a follow-up study after 5 years. Eur J Surg Oncol. 2009 Feb;35(2):159-63. doi: 10.1016/j.ejso.2008.07.017. Epub 2008 Sep 11.
- Background: PubMed 12711294van Berlo CL, Hess DA, Nijhuis PA, Leys E, Gerritsen HA, Schapers RF. Ambulatory sentinel node biopsy under local anaesthesia for patients with early breast cancer. Eur J Surg Oncol. 2003 May;29(4):383-5. doi: 10.1053/ejso.2002.1420.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conservative surgery for breast cancer with local anesthesia and conservative surgery for breast cancer with general anesthesia in people with Breast Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 7 inclusion and 15 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 4 Apr 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 France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study. (time frame: 2 years). The study lists 4 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 NCT06910280, which also lists 23 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 4 Apr 2025.