Sterilization TubalSALSTERNCT03860805
SALpingectomy for STERilization (SALSTER)
A study testing Laparoscopic tubal ligation and Laparoscopic bilateral salpingectomy in people with Sterilization Tubal and Salpingectomy, run by Göteborg University at 1 site in Sweden.
Trial summary
The SALSTER study is a register-based randomized clinical trial (R-RCT) that examines if laparoscopic salpingectomy instead of tubal ligation, as a contraceptive method, has no increased risk for complications and has no negative impact on ovarian function. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sterilization Tubal, Salpingectomy, Laparoscopy
- What is being tested?
- Laparoscopic tubal ligation and Laparoscopic bilateral salpingectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteSweden
- Study dates
- 3 Apr 2019to 31 Dec 2050
- 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 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Planned laparoscopic sterilization
- Willing to be randomized
Who cannot join
- Women older than 49
- Not understanding the oral or written study information
- Previous malignancy involving radiation, chemotherapy or endocrine treatment affecting ovarian function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SALpingectomy for STERilization (SALSTER); a Randomized Trial
The SALSTER study is a register-based randomized clinical trial (R-RCT) that examines if laparoscopic salpingectomy instead of tubal ligation, as a contraceptive method, has no increased risk for complications and has no negative impact on ovarian function.
Read the detailed description
SALSTER Study
In the last years, the management of Fallopian tubes in benign surgery has drawn a lot of attention due to rising evidence showing that some aggressive forms of ovarian cancer may originate from the distal Fallopian tubes. Concerns were raised about the implications of salpingectomy to surgical outcome and function of the ovaries. The SALSTER study attempts to evaluate the effect of salpingectomy, in regards to surgical outcomes and ovarian function, in women seeking permanent contraception with tubal ligation.
The SALSTER study is a register-based randomized clinical trial (R-RCT) that examines if laparoscopic salpingectomy instead of tubal ligation, as a contraceptive method, has no increased risk for complications and has no negative impact on ovarian function. Complications will be assessed primarily at eight weeks post-surgery according to the Clavien-Dindo classification and the existing complications questionnaires in the Swedish National Quality Register of Gynecological Surgery (GynOp). Ovarian function will be primarily assessed by determining the age of natural menopause, measured through questionnaires on bleeding pattern in GynOp every other year. Approximately 900 patients will be recruited.
In a subset of patients, the difference in Anti-Müllerian Hormone (AMH) levels from the time of surgery and 1-year after surgery will be compared between the groups. Approximately 180 patients will be recruited.
The study is expected to start in the beginning of 2019 and the first results are expected in 2021.
- Conditions
- Sterilization Tubal, Salpingectomy, Laparoscopy, Ovarian Reserve
- Being tested
- Laparoscopic tubal ligation, Laparoscopic bilateral salpingectomy
- Keywords
- Sterilization Tubal, Salpingectomy, Laparoscopy, Ovarian Reserve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic tubal ligationProcedure or surgery
Laparoscopic tubal ligation
Laparoscopic bilateral salpingectomyProcedure or surgery
Laparoscopic bilateral salpingectomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic tubal ligation | Active comparator | Patients who seek for surgical permanent contraception and randomized to laparoscopic tubal ligation Receives: Procedure: Laparoscopic tubal ligation |
| Laparoscopic bilateral salpingectomy | Active comparator | Patients who seek for surgical permanent contraception and randomized to laparoscopic bilateral salpingectomy Receives: Procedure: Laparoscopic bilateral salpingectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Complication according to the Clavien-Dindo classification or specific questions on complications in GynOp Register (Swedish National Quality Register of Gynecological Surgery). Binary data.
Measured: Eight weeks post-operatively
Age at menopause
Determined from questionnaires on bleeding pattern in GynOp. Continuous data.
Measured: Twenty years
Secondary outcomes (14)
Severe complications
Complications according to the Clavien-Dindo classification or the specific questions on complications in GynOp. Binary data.
Measured: Eight weeks post-operatively
Operative time
In minutes. Continous data.
Measured: At day of surgery
Perioperative blood loss
In millilitres. Continous data.
Measured: At day of surgery
Length of hospital stay
In Days. Continous data.
Measured: Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks
Complications according to Clavien-Dindo
Assessed according to Clavien-Dindo. Binary data.
Measured: One year after surgery
Complications
Assessed according to the existing questions on complications in GynOp. Binary data.
Measured: One year after surgery
Age at the start of the perimenopausal state
Assessed through questionnaires in GynOp. Continous data.
Measured: Up to 55 years of age
Length of the perimenopausal state
Assessed in GynOp. Measured in days. Continous data.
Measured: Up to 55 years of age
Change in menopausal symptom score
Assessed with Menopause Rating Scale (MRS) in GynOp. MRS is a validated scale consisting of 11 questions, each yields a score of 1-4. Total score is reported, ranging from 4 to 44, where 4 indicates no menopausal symptoms and 44 maximum symptoms. Ordered categorical data.
Measured: Up to 55 years of age
Use of hormone replacement therapy at any time during follow-up
Either an answer yes to question in GynOp or prescription in The Drug Prescription Register will give information on the outcome (yes/no). Binary data.
Measured: Up to 55 years of age
Subsequent surgery on uterus, salpinges and/or ovaries. Binary data.
Assessed through GynOp and through The Patient register. Both registers yield the same data (subsequent surgery yes/no). Binary data.
Measured: At one year and up to 55 years of age
Pregnancy
Assessed in GynOp, whether pregnancy has occurred (yes/no). Binary data.
Measured: At one year and up to 55 years of age
Epithelial ovarian cancer including histopathological types and grade, primary tubal and peritoneal cancer, as well as clinical stage according to International Federation of Gynecology and Obstetrics (FIGO)
Assessed through The Swedish Cancer Register, The Swedish Quality Register for Gynaecological Cancer, The Swedish Cause of Death Register and The Swedish Population Register. Time-to event data.
Measured: 40 years
Secondary expressions of estrogen deficiency
Measures of fractures related to osteoporosis and cardio-vascular events will be assessed through the Patient register. Binary and time-to-event data.
Measured: 40 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start3 Apr 2019
- Primary completionApr 2043 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Sterilization TubalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University
- Responsible party
- Sponsor
- Investigators
- Annika Strandell, Principal investigator, Sahlgrenska Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860805
- Sponsor's protocol ID
- 316-18
- Acronym
- SALSTER
- Status last verified
- Jan 2025
- First submitted
- 30 Oct 2018
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Collins, E., Strandell, A., Granåsen, G., I. A. (2018). Increased risk of menopausal symptoms one year after opportunistic salpingectomy - A retrospective observational cohort study based on the Swedish National Quality Register of Gynecological Surgery. Paris: EBCOG. Retrieved from http://www.ebcog2018.org/content/detailed-program
Dilley SE, Havrilesky LJ, Bakkum-Gamez J, Cohn DE, Michael Straughn J Jr, Caughey AB, Rodriguez MI. Cost-effectiveness of opportunistic salpingectomy for ovarian cancer prevention. Gynecol Oncol. 2017 Aug;146(2):373-379. doi: 10.1016/j.ygyno.2017.05.034. Epub 2017 Jun 1.
PubMed 28577884Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Falconer H, Yin L, Gronberg H, Altman D. Ovarian cancer risk after salpingectomy: a nationwide population-based study. J Natl Cancer Inst. 2015 Jan 27;107(2):dju410. doi: 10.1093/jnci/dju410. Print 2015 Feb.
PubMed 25628372Ganer Herman H, Gluck O, Keidar R, Kerner R, Kovo M, Levran D, Bar J, Sagiv R. Ovarian reserve following cesarean section with salpingectomy vs tubal ligation: a randomized trial. Am J Obstet Gynecol. 2017 Oct;217(4):472.e1-472.e6. doi: 10.1016/j.ajog.2017.04.028. Epub 2017 Apr 25.
PubMed 28455082Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45.
PubMed 15345062Helden JV, Weiskirchen R. Age-independent anti-Mullerian hormone (AMH) standard deviation scores to estimate ovarian function. Eur J Obstet Gynecol Reprod Biol. 2017 Jun;213:64-70. doi: 10.1016/j.ejogrb.2017.04.029. Epub 2017 Apr 18.
PubMed 28437631Kotlyar A, Gingold J, Shue S, Falcone T. The Effect of Salpingectomy on Ovarian Function. J Minim Invasive Gynecol. 2017 May-Jun;24(4):563-578. doi: 10.1016/j.jmig.2017.02.014. Epub 2017 Feb 20.
PubMed 28223181Labidi-Galy SI, Papp E, Hallberg D, Niknafs N, Adleff V, Noe M, Bhattacharya R, Novak M, Jones S, Phallen J, Hruban CA, Hirsch MS, Lin DI, Schwartz L, Maire CL, Tille JC, Bowden M, Ayhan A, Wood LD, Scharpf RB, Kurman R, Wang TL, Shih IM, Karchin R, Drapkin R, Velculescu VE. High grade serous ovarian carcinomas originate in the fallopian tube. Nat Commun. 2017 Oct 23;8(1):1093. doi: 10.1038/s41467-017-00962-1.
PubMed 29061967McKinlay SM, Brambilla DJ, Posner JG. The normal menopause transition. Maturitas. 1992 Jan;14(2):103-15. doi: 10.1016/0378-5122(92)90003-m.
PubMed 1565019Shih IeM, Kurman RJ. Ovarian tumorigenesis: a proposed model based on morphological and molecular genetic analysis. Am J Pathol. 2004 May;164(5):1511-8. doi: 10.1016/s0002-9440(10)63708-x.
PubMed 15111296Shinar S, Blecher Y, Alpern S, Many A, Ashwal E, Amikam U, Cohen A. Total bilateral salpingectomy versus partial bilateral salpingectomy for permanent sterilization during cesarean delivery. Arch Gynecol Obstet. 2017 May;295(5):1185-1189. doi: 10.1007/s00404-017-4340-x. Epub 2017 Mar 11.
PubMed 28285425Tehrani FR, Mansournia MA, Solaymani-Dodaran M, Azizi F. Age-specific serum anti-Mullerian hormone levels: estimates from a large population-based sample. Climacteric. 2014 Oct;17(5):591-7. doi: 10.3109/13697137.2014.912262. Epub 2014 Jul 9.
PubMed 24716733Trabuco EC, Moorman PG, Algeciras-Schimnich A, Weaver AL, Cliby WA. Association of Ovary-Sparing Hysterectomy With Ovarian Reserve. Obstet Gynecol. 2016 May;127(5):819-827. doi: 10.1097/AOG.0000000000001398.
PubMed 27054925Wang Y, Mang M, Wang Y, Wang L, Klein R, Kong B, Zheng W. Tubal origin of ovarian endometriosis and clear cell and endometrioid carcinoma. Am J Cancer Res. 2015 Feb 15;5(3):869-79. eCollection 2015.
PubMed 26045974
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SALpingectomy for STERilization (SALSTER); a Randomized Trial
- ClinicalTrials.gov ID
- NCT03860805
- Acronym / sponsor ID
- SALSTER / 316-18
- Conditions
- Sterilization Tubal, Salpingectomy, Laparoscopy, Ovarian Reserve
- Keywords
- Sterilization Tubal, Salpingectomy, Laparoscopy, Ovarian Reserve
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Umeå University
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- Apr 2043 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 4 Mar 2019 (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 SALSTER study is a register-based randomized clinical trial (R-RCT) that examines if laparoscopic salpingectomy instead of tubal ligation, as a contraceptive method, has no increased risk for complications and has no negative impact on ovarian function.
Detailed description
SALSTER Study
In the last years, the management of Fallopian tubes in benign surgery has drawn a lot of attention due to rising evidence showing that some aggressive forms of ovarian cancer may originate from the distal Fallopian tubes. Concerns were raised about the implications of salpingectomy to surgical outcome and function of the ovaries. The SALSTER study attempts to evaluate the effect of salpingectomy, in regards to surgical outcomes and ovarian function, in women seeking permanent contraception with tubal ligation.
The SALSTER study is a register-based randomized clinical trial (R-RCT) that examines if laparoscopic salpingectomy instead of tubal ligation, as a contraceptive method, has no increased risk for complications and has no negative impact on ovarian function. Complications will be assessed primarily at eight weeks post-surgery according to the Clavien-Dindo classification and the existing complications questionnaires in the Swedish National Quality Register of Gynecological Surgery (GynOp). Ovarian function will be primarily assessed by determining the age of natural menopause, measured through questionnaires on bleeding pattern in GynOp every other year. Approximately 900 patients will be recruited.
In a subset of patients, the difference in Anti-Müllerian Hormone (AMH) levels from the time of surgery and 1-year after surgery will be compared between the groups. Approximately 180 patients will be recruited.
The study is expected to start in the beginning of 2019 and the first results are expected in 2021.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic tubal ligation | Active comparator | Procedure: Laparoscopic tubal ligationPatients who seek for surgical permanent contraception and randomized to laparoscopic tubal ligation |
| Laparoscopic bilateral salpingectomy | Active comparator | Procedure: Laparoscopic bilateral salpingectomyPatients who seek for surgical permanent contraception and randomized to laparoscopic bilateral salpingectomy |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Planned laparoscopic sterilization
- Willing to be randomized
Key exclusion criteria (3 listed)
- Women older than 49
- Not understanding the oral or written study information
- Previous malignancy involving radiation, chemotherapy or endocrine treatment affecting ovarian function
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 |
|---|---|---|
| Laparoscopic tubal ligationLaparoscopic tubal ligation | Procedure or surgery | Laparoscopic tubal ligation |
| Laparoscopic bilateral salpingectomyLaparoscopic bilateral salpingectomy | Procedure or surgery | Laparoscopic bilateral salpingectomy |
Primary outcome
Complications
Time frame: Eight weeks post-operatively
Complication according to the Clavien-Dindo classification or specific questions on complications in GynOp Register (Swedish National Quality Register of Gynecological Surgery). Binary data.
Age at menopause
Time frame: Twenty years
Determined from questionnaires on bleeding pattern in GynOp. Continuous data.
14 secondary outcomes
Severe complications
Time frame: Eight weeks post-operatively
Operative time
Time frame: At day of surgery
Perioperative blood loss
Time frame: At day of surgery
Length of hospital stay
Time frame: Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks
Complications according to Clavien-Dindo
Time frame: One year after surgery
Complications
Time frame: One year after surgery
Age at the start of the perimenopausal state
Time frame: Up to 55 years of age
Length of the perimenopausal state
Time frame: Up to 55 years of age
Change in menopausal symptom score
Time frame: Up to 55 years of age
Use of hormone replacement therapy at any time during follow-up
Time frame: Up to 55 years of age
Subsequent surgery on uterus, salpinges and/or ovaries. Binary data.
Time frame: At one year and up to 55 years of age
Pregnancy
Time frame: At one year and up to 55 years of age
Epithelial ovarian cancer including histopathological types and grade, primary tubal and peritoneal cancer, as well as clinical stage according to International Federation of Gynecology and Obstetrics (FIGO)
Time frame: 40 years
Secondary expressions of estrogen deficiency
Time frame: 40 years
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 17 Jan 2025.
- BackgroundCollins, E., Strandell, A., Granåsen, G., I. A. (2018). Increased risk of menopausal symptoms one year after opportunistic salpingectomy - A retrospective observational cohort study based on the Swedish National Quality Register of Gynecological Surgery. Paris: EBCOG. Retrieved from http://www.ebcog2018.org/content/detailed-program
- Background: PubMed 28577884Dilley SE, Havrilesky LJ, Bakkum-Gamez J, Cohn DE, Michael Straughn J Jr, Caughey AB, Rodriguez MI. Cost-effectiveness of opportunistic salpingectomy for ovarian cancer prevention. Gynecol Oncol. 2017 Aug;146(2):373-379. doi: 10.1016/j.ygyno.2017.05.034. Epub 2017 Jun 1.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Background: PubMed 25628372Falconer H, Yin L, Gronberg H, Altman D. Ovarian cancer risk after salpingectomy: a nationwide population-based study. J Natl Cancer Inst. 2015 Jan 27;107(2):dju410. doi: 10.1093/jnci/dju410. Print 2015 Feb.
- Background: PubMed 28455082Ganer Herman H, Gluck O, Keidar R, Kerner R, Kovo M, Levran D, Bar J, Sagiv R. Ovarian reserve following cesarean section with salpingectomy vs tubal ligation: a randomized trial. Am J Obstet Gynecol. 2017 Oct;217(4):472.e1-472.e6. doi: 10.1016/j.ajog.2017.04.028. Epub 2017 Apr 25.
- Background: PubMed 15345062Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45.
- Background: PubMed 28437631Helden JV, Weiskirchen R. Age-independent anti-Mullerian hormone (AMH) standard deviation scores to estimate ovarian function. Eur J Obstet Gynecol Reprod Biol. 2017 Jun;213:64-70. doi: 10.1016/j.ejogrb.2017.04.029. Epub 2017 Apr 18.
- Background: PubMed 28223181Kotlyar A, Gingold J, Shue S, Falcone T. The Effect of Salpingectomy on Ovarian Function. J Minim Invasive Gynecol. 2017 May-Jun;24(4):563-578. doi: 10.1016/j.jmig.2017.02.014. Epub 2017 Feb 20.
- Background: PubMed 29061967Labidi-Galy SI, Papp E, Hallberg D, Niknafs N, Adleff V, Noe M, Bhattacharya R, Novak M, Jones S, Phallen J, Hruban CA, Hirsch MS, Lin DI, Schwartz L, Maire CL, Tille JC, Bowden M, Ayhan A, Wood LD, Scharpf RB, Kurman R, Wang TL, Shih IM, Karchin R, Drapkin R, Velculescu VE. High grade serous ovarian carcinomas originate in the fallopian tube. Nat Commun. 2017 Oct 23;8(1):1093. doi: 10.1038/s41467-017-00962-1.
- Background: PubMed 1565019McKinlay SM, Brambilla DJ, Posner JG. The normal menopause transition. Maturitas. 1992 Jan;14(2):103-15. doi: 10.1016/0378-5122(92)90003-m.
- Background: PubMed 15111296Shih IeM, Kurman RJ. Ovarian tumorigenesis: a proposed model based on morphological and molecular genetic analysis. Am J Pathol. 2004 May;164(5):1511-8. doi: 10.1016/s0002-9440(10)63708-x.
- Background: PubMed 28285425Shinar S, Blecher Y, Alpern S, Many A, Ashwal E, Amikam U, Cohen A. Total bilateral salpingectomy versus partial bilateral salpingectomy for permanent sterilization during cesarean delivery. Arch Gynecol Obstet. 2017 May;295(5):1185-1189. doi: 10.1007/s00404-017-4340-x. Epub 2017 Mar 11.
- 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.
Annika Strandell principal investigator
Sahlgrenska Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic tubal ligation and Laparoscopic bilateral salpingectomy in people with Sterilization Tubal and Salpingectomy, run by Göteborg University at 1 site in Sweden.
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 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jan 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 Sweden. 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?
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?
Complications (time frame: Eight weeks post-operatively). 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 NCT03860805, which also lists 17 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 17 Jan 2025.