LipedemaLIPLEGNCT04272827
Evaluation Between Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy (CDT) Alone
A study testing Liposuction in people with Lipedema, run by Hautklinik Darmstadt at 12 sites in Germany.
Trial summary
The purpose of this study is to determine whether surgical treatment of lipedema (stage I, II or III) using liposuction significantly improves leg pain compared to the use of complex decongestive therapy (CDT). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Liposuction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 12 sitesGermany
- Study dates
- 15 Jan 2021to 1 Sep 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- Female
- Age ≥ 18 years
- Confirmed lipedema of the legs in stage I, II or III
- Average pain in the legs for the last four weeks ≥ 4 points on a numerical rating scale
- Documentation of insufficient relief of symptoms by conservative measures
- Willingness and ability to perform conservative measures according to the study protocol, during and, if necessary, after liposuction treatment
- Full legal capacity
Who cannot join
- Concurrent lipedema of the arms and legs, in which co-occurrence of lipedema in the arms affects the primary endpoint (i.e., average leg pain), at the discretion of the study investigator
- Previous liposuctions
- Diseases that may limit operability at the discretion of the study physician, e.g. cardiac diseases, coagulation disorders, metabolic diseases, infectious diseases (active), epilepsy; diseases requiring immunosuppression or anticoagulation with medication; allergies to medication accompanying surgery
- Weight >120.0 kg
- Medical conditions that affect adequate complex decongestive therapy (CDT) at the discretion of the study physician, e.g. heart failure (volume stress), lack of physical ability to wear compression stockings (e.g. joint disease, neurological deficits).
- Primary obesity without disproportion and without evidence of lipedema
Show all 15Show fewer
- Secondary obesity
- Fat distribution disorders of other genesis (e.g. painless lipohypertrophy, benign symmetric lipomatoses or lipomatosis dolorosa)
- Other edema-causing diseases (such as lymphedema, phlebedema, or myxedema)
- Lack of willingness to ensure adequate contraception
- Positive pregnancy test
- Breastfeeding
- Use of a lymphomat
- Participation in other clinical studies
- Purely cosmetic reasons for participation in the study
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Hautmedizin Bad Soden
Bad Soden am Taunus, Hesse, 65812
Johanniter GmbH Waldkrankenhaus Bonn
Bonn, North Rhine-Westphalia, 53177
Klinik und Praxisklinik für Plastische Chirurgie
Cologne, North Rhine-Westphalia, 50668
MVZ Praxis
Cologne, North Rhine-Westphalia, 51069
Hautklinik Darmstadt
Darmstadt, Hesse, 64283
MVZ Praxis Dr. Cornely Düsseldorf MVZ Corius Nordrhein GmbH
Düsseldorf, North Rhine-Westphalia, 40474
Praxis für Dermatologie, Dermatochirurgie und Phlebologie
Freiburg im Breisgau, Baden-Wurttemberg, 79098
Venenzentrum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79108
Hautarztpraxis Mühltal
Mühltal, Hesse, 64367
Evangelisches Krankenhaus Oldenburg Klinik für Plastische, Ästhetische, Rekonstruktive und Handchirurgie
Oldenburg, Lower Saxony, 26122
Klinikum Ernst von Bergmann
Potsdam, Brandenburg, 14467
Universitätsklinikum Regensburg
Regensburg, Bavaria, 93053
About this study
Official title: Multicentre, Controlled, Randomized, Investigator-blinded Clinical Trial on Efficacy and Safety of Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy Alone (LIPLEG)
The purpose of this study is to determine whether surgical treatment of lipedema (stage I, II or III) using liposuction significantly improves leg pain compared to the use of complex decongestive therapy (CDT).
Read the detailed description
After being informed about the study and potential risks, all patients that gave written informed consent will undergo a run-in phase of up to seven months for edema elimination and maintenance of results using complex decongestive therapy (CDT). Afterwards, patients will be assigned to one of the two treatment groups via internet randomization, provided that all inclusion and exclusion criteria continue to be met. Randomization will be 2:1 (intervention: control). In the intervention arm, patients will receive liposuction treatment (number of surgeries at the discretion of the treating study physician: a maximum of four surgical procedures, with a minimum of 5 and a maximum of 7 weeks between each surgery) with, if necessary, concomitant CDT to maintain the surgical results as required by the patient.
The primary endpoint (regarding pain in the legs in stages I, II or III) will be assessed after an observation period of 12 months after final liposuction surgery. This is followed by a further follow-up period for 24 months to observe and document the further course.
- Conditions
- Lipedema
- Being tested
- Liposuction
- Keywords
- Lipedema, complex decongestive therapy(CDT), liposuction
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiposuctionProcedure or surgery
Liposuction treatment will be performed according to the study protocol using the "wet technique" depending on the amount of fat to be removed, if necessary in several sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | In the intervention group, patients will receive liposuction treatment (number of surgeries at the discretion of the attending study physician: a maximum of 4 surgical procedures, with a minimum of 5 and a maximum of 7 weeks between each surgery) with concomitant complex decongestive therapy (CDT), if necessary, to maintain surgical outcomes as required by the patient. Receives: Procedure: Liposuction |
| Control group | Other | After randomisation, the control group will be treated for 12 months with complex decongestive therapy (CDT) alone.
After these 12 months, patients can opt for liposuction treatment if they continue to meet the inclusion and exclusion criteria. Receives: Procedure: Liposuction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Pain Reduction After 12 Months (≥ 2 Points on a Numeric Rating Scale)
The primary end point is the relevant reduction of the average pain of the last four weeks in the legs (≥ 2 points on a Numeric Rating Scale; German Pain Questionnaire) 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation.
Measured: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Secondary outcomes (16)
Change in Pain Severity as Assessed by German Pain Questionnaire
Change in severity according to von Korff et al. (1992) regarding pain in the legs (stage I, II or III). The severity is calculated based on the questions of the German Pain Questionnaire according to von Korff et al (1992). The assessment of the pain intensity as well as the impairment and information on the days of impairment are included in the calculation of the severity (classes 0 = no pain to 4 = high, pain-related impairment, strongly limiting).
Measured: 12 months after completed liposuction treatment (intervention group) or after randomization (control group) compared with the time of randomisation)
Change in Health-Related Quality of Life According to SF-36 Questionnaire
Change in health-related quality of life according to SF-36 questionnaire.
Measured: 12 months after completed liposuction treatment (intervention group) or after randomization (control group) compared with the time of randomisation)
Change in Health-Related Quality of Life According to DLQI Questionnaire
Change in health-related quality of life according to DLQI questionnaire (a clinically relevant change corresponds to ≥ 4 points change in DLQI sum score).
Measured: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Change in Health-Related Quality of Life According to WHOQOL-BREF Questionnaire
Change in health-related quality of life according to WHOQOL-BREF questionnaire.
Measured: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Change in Total Impairment According to Schmeller et al. (2010)
Total impairment is measured by taking the mean of 7 numerical rating scales assessing the domains pain (spontaneous, pressure), swelling, hematoma, movement, cosmetic appearance and quality of life (0 (none) - 10 (always/very strong) points), see Schmeller et al. (2010).
Measured: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Altered Depression Tendency According to PHQ-9 Questionnaire
Altered depression tendency according to PHQ-9 questionnaire (a clinically relevant improvement corresponds to ≥ 5 points reduction in PHQ-9 sum score).
Measured: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Altered Hematoma Tendency According to Schmeller et al. (2010)
Hematoma ("Are you prone to bruising?") is measured by a numerical rating scale (0 (none) - 10 (always/very strong) points), see Schmeller et al. (2010).
Measured: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Changed Prevalence of Edema
Changed prevalence of edema
Measured: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Change in the Scope of the Physical Therapy
The scope of the physical therapy is measured by the number of treatment sessions per month.
Measured: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Change in Body Fat Percentage According to Wright et al. (1981)
Change in body fat percentage, determined according to formula from Wright et al. (1981), collected by means of measuring tape at the following points:
- abdominal circumference: measurement at the level of the navel. The tape measure is placed horizontally around the body
- neck circumference: measurement below the larynx
- body size
- hip circumference: the widest part of the hip is measured.
Measured: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Change of Leg Circumference by Means of Measuring Tape
Change of leg circumference of the left and right leg by means of measuring tape at five specified measuring points:
- lower leg cuffs
- calf center
- knee
- 10 cm below the groin
- hips (iliac crest).
Measured: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Movement Restriction Reduction According to LEFS Sum Score
Relevant reduction in movement restriction (stage I, II, or III; ≥ 9 points improvement in LEFS sum score)
Measured: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Number of Recurrent Interventions
Number of recurrent interventions
Measured: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Number of (Serious) Adverse Events
Number of (serious) adverse events
Measured: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Number of Therapy Interruptions Caused by Adverse Events
Discontinuation of therapy caused by adverse events
Measured: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Optional: Change of the Leg Volume by Means of Perometry
Optional: Change of the leg volume of the left and right leg (e.g. by means of perometry etc.)
Measured: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start15 Jan 2021
- Primary completion31 Aug 2024
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LipedemaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After a run in phase, randomization is performed in the intervention and control arm (2:1).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hautklinik Darmstadt
- Sponsor type
- University, hospital or other
- Collaborators
- The Clinical Trials Centre Cologne
- Responsible party
- Sponsor
- Investigators
- Maurizio Podda, Dr. med., Study chair, Hautklink Darmstadt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272827
- Sponsor's protocol ID
- LIPLEG-3806
- Acronym
- LIPLEG
- Status last verified
- Mar 2024
- First submitted
- 12 Feb 2020
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Podda M, Schmidt J, Cornely ME, Steinmetz MI, Rajewski D, Busch KH, Taufig Z, Ghods M, Kovacs M, Schmid S, Kraus D, Hellmich M, Muller W, Schiller P, Cornely OA. Liposuction versus conservative therapy for patients with lipoedema in Germany: a multicentre, randomised controlled clinical trial. Lancet. 2026 Sep 5;408(10558):910-923. doi: 10.1016/S0140-6736(26)00910-4.
PubMed 42692034Podda M, Kovacs M, Hellmich M, Roth R, Zarrouk M, Kraus D, Prinz-Langenohl R, Cornely OA. A randomised controlled multicentre investigator-blinded clinical trial comparing efficacy and safety of surgery versus complex physical decongestive therapy for lipedema (LIPLEG). Trials. 2021 Oct 30;22(1):758. doi: 10.1186/s13063-021-05727-2.
PubMed 34717741
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Controlled, Randomized, Investigator-blinded Clinical Trial on Efficacy and Safety of Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy Alone (LIPLEG)
- ClinicalTrials.gov ID
- NCT04272827
- Acronym / sponsor ID
- LIPLEG / LIPLEG-3806
- Conditions
- Lipedema
- Keywords
- Lipedema, complex decongestive therapy(CDT), liposuction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Hautklinik DarmstadtUniversity, hospital or other
- Collaborators
- The Clinical Trials Centre Cologne
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 17 Feb 2020 (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 purpose of this study is to determine whether surgical treatment of lipedema (stage I, II or III) using liposuction significantly improves leg pain compared to the use of complex decongestive therapy (CDT).
Detailed description
After being informed about the study and potential risks, all patients that gave written informed consent will undergo a run-in phase of up to seven months for edema elimination and maintenance of results using complex decongestive therapy (CDT). Afterwards, patients will be assigned to one of the two treatment groups via internet randomization, provided that all inclusion and exclusion criteria continue to be met. Randomization will be 2:1 (intervention: control). In the intervention arm, patients will receive liposuction treatment (number of surgeries at the discretion of the treating study physician: a maximum of four surgical procedures, with a minimum of 5 and a maximum of 7 weeks between each surgery) with, if necessary, concomitant CDT to maintain the surgical results as required by the patient.
The primary endpoint (regarding pain in the legs in stages I, II or III) will be assessed after an observation period of 12 months after final liposuction surgery. This is followed by a further follow-up period for 24 months to observe and document the further course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- After a run in phase, randomization is performed in the intervention and control arm (2:1).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Procedure: LiposuctionIn the intervention group, patients will receive liposuction treatment (number of surgeries at the discretion of the attending study physician: a maximum of 4 surgical procedures, with a minimum of 5 and a maximum of 7 weeks between each surgery) with concomitant complex decongestive therapy (CDT), if necessary, to maintain surgical outcomes as required by the patient. |
| Control group | Other | Procedure: LiposuctionAfter randomisation, the control group will be treated for 12 months with complex decongestive therapy (CDT) alone. After these 12 months, patients can opt for liposuction treatment if they continue to meet the inclusion and exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent form
- Female
- Age ≥ 18 years
- Confirmed lipedema of the legs in stage I, II or III
- Average pain in the legs for the last four weeks ≥ 4 points on a numerical rating scale
Key exclusion criteria (15 listed)
- Concurrent lipedema of the arms and legs, in which co-occurrence of lipedema in the arms affects the primary endpoint (i.e., average leg pain), at the discretion of the study investigator
- Previous liposuctions
- Diseases that may limit operability at the discretion of the study physician, e.g. cardiac diseases, coagulation disorders, metabolic diseases, infectious diseases (active), epilepsy; diseases requiring immunosuppression or anticoagulation with medication; allergies to medication accompanying surgery
- Weight >120.0 kg
- Medical conditions that affect adequate complex decongestive therapy (CDT) at the discretion of the study physician, e.g. heart failure (volume stress), lack of physical ability to wear compression stockings (e.g. joint disease, neurological deficits).
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 |
|---|---|---|
| LiposuctionLiposuction treatment will be performed according to the study protocol using the "wet technique" depending on the amount of fat to be removed, if necessary in several sessions. | Procedure or surgery | Control group, Intervention group |
Primary outcome
Successful Pain Reduction After 12 Months (≥ 2 Points on a Numeric Rating Scale)
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
The primary end point is the relevant reduction of the average pain of the last four weeks in the legs (≥ 2 points on a Numeric Rating Scale; German Pain Questionnaire) 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation.
16 secondary outcomes
Change in Pain Severity as Assessed by German Pain Questionnaire
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomization (control group) compared with the time of randomisation)
Change in Health-Related Quality of Life According to SF-36 Questionnaire
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomization (control group) compared with the time of randomisation)
Change in Health-Related Quality of Life According to DLQI Questionnaire
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Change in Health-Related Quality of Life According to WHOQOL-BREF Questionnaire
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Change in Total Impairment According to Schmeller et al. (2010)
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Altered Depression Tendency According to PHQ-9 Questionnaire
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Altered Hematoma Tendency According to Schmeller et al. (2010)
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Changed Prevalence of Edema
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Change in the Scope of the Physical Therapy
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Change in Body Fat Percentage According to Wright et al. (1981)
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Change of Leg Circumference by Means of Measuring Tape
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Movement Restriction Reduction According to LEFS Sum Score
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Number of Recurrent Interventions
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Number of (Serious) Adverse Events
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Number of Therapy Interruptions Caused by Adverse Events
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Optional: Change of the Leg Volume by Means of Perometry
Time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Derived from this study: PubMed 42692034Podda M, Schmidt J, Cornely ME, Steinmetz MI, Rajewski D, Busch KH, Taufig Z, Ghods M, Kovacs M, Schmid S, Kraus D, Hellmich M, Muller W, Schiller P, Cornely OA. Liposuction versus conservative therapy for patients with lipoedema in Germany: a multicentre, randomised controlled clinical trial. Lancet. 2026 Sep 5;408(10558):910-923. doi: 10.1016/S0140-6736(26)00910-4.
- Derived from this study: PubMed 34717741Podda M, Kovacs M, Hellmich M, Roth R, Zarrouk M, Kraus D, Prinz-Langenohl R, Cornely OA. A randomised controlled multicentre investigator-blinded clinical trial comparing efficacy and safety of surgery versus complex physical decongestive therapy for lipedema (LIPLEG). Trials. 2021 Oct 30;22(1):758. doi: 10.1186/s13063-021-05727-2.
- 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.
Maurizio Podda, Dr. med. study chair
Hautklink Darmstadt
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposuction in people with Lipedema, run by Hautklinik Darmstadt at 12 sites in Germany.
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 8 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: status not confirmed, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. 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?
Results are not available in the source record.
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?
Successful Pain Reduction After 12 Months (≥ 2 Points on a Numeric Rating Scale) (time frame: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)). 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 NCT04272827, which also lists 2 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 19 Mar 2025.