Endometrial Polyp BenignNCT05811286
The Use of a Morcellator in Operative Hysteroscopy for Benign Intracavitary Lesions: a Feasibility Study
A study testing Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions in people with Endometrial Polyp Benign and Retained Products of Conception, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial summary
Polyps, intracavitary myomas and retained products of conception (RPOC) are common benign intracavitary lesions of the uterus and frequently cause abnormal uterine bleeding or pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Polyp Benign, Retained Products of Conception, Myoma;Uterus
- What is being tested?
- Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesBelgium
- Study dates
- 20 May 2021to 28 Jun 2023
- 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
- Patients:
- Female
- Ultrasonographic diagnosis of an intracavitary lesion, according the IETA terms and definitions
- endometrial polyp
- FIGO 0-1 myoma (maximum diameter 2 cm)
- RPOC (maximum diameter 2 cm, no enhanced myometrial vascularity)
Who cannot join
- • Active vaginal bleeding
- (possible) malignancy
- < 18y
- Patient refusal
- Pregnancy
- Impossibility to access the uterine cavity (e.g. severe cervical stenosis)
- Absence of intracavitary lesion (endometrial polyp, FIGO 0-1 myoma or RPOC) at hysteroscopy
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ziekenhuis Oost-Limburg
Genk
University Hospitals Leuven
Leuven, 3000
About this study
Polyps, intracavitary myomas and retained products of conception (RPOC) are common benign intracavitary lesions of the uterus and frequently cause abnormal uterine bleeding or pain. In general, intracavitary lesions are treated by operative hysteroscopy with bipolar resectoscopic removal under general anaesthesia, performed in the theatre (OR). Potential problems with this approach are thermal damage and impairment of visibility due to loose tissue fragments necessitating multiple entries for tissue removal.
Recently, lesion morcellation by hysteroscopy has been introduced as an alternative technique. Compared to the resectoscopic approach, morcellation is reportedly associated with a shorter total procedure time, smaller fluid deficit and number of insertions. A few trials also registered a higher success rate in completeness of resection.
Read more
No significant differences in odds of surgical complications have been reported.
Most hysteroscopic morcellators have diameters up to 8 mm, for which cervical dilation under general anaesthesia is usually needed.
Recently, companies have developed hysteroscopic morcellators with smaller diameters, e.g. 6.3 mm for the 19 Fr. intrauterine BIGATTI Shaver (IBS®). This means less need for cervical dilation, and potential use without anesthesia.
At this moment, there are no prospective studies available on feasibility of the 19 Fr. intrauterine BIGATTI Shaver (IBS®). Before implementing hysteroscopic morcellation in our department, we need a feasibility study assessing the method in standard conditions in the operation room or in ambulatory setting under sedation.
Trial objectives:
Assessment of the feasibility of hysteroscopic morcellation of benign uterine intracavitary lesions. The primary objective is to assess the completeness of hysteroscopic resection in patients undergoing the procedure under general anesthesia or sedation.
Secondary objectives are to assess perioperative parameters as operation time, need for cervical dilation, adverse events, pain, operator satisfaction; to assess quality of tissue for histological examination; to assess postoperative complications and pain.
- Being tested
- Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions
- Keywords
- Endometrial polyp, Hysteroscopic surgery, Morcellation, Retained products of conception, Myoma
- Medical subject headings
- Myofibroma, Myoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesionsProcedure or surgery
With the shaver, the lesion is removed in the OR. We will include endometrial polyps, FIGO 0-1 myomas and retained products of conception.
We will assess the completeness of hysteroscopic resection, operation time, need for cervical dilation, adverse events, pain, operator satisfaction; quality of tissue for histological examination, postoperative complications and pain.
| Study group | Role | What they receive |
|---|---|---|
| Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions | Experimental | Single experimental arm of patients with a intracavitary lesion and elligible for hysteroscopic morcellation. Receives: Procedure: Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness of resection of intracavitary lesions in 50 patients, when using a hysteroscopic Bigatti Shaver.
If all tissue could be removed by the 19 Fr. intrauterine BIGATTI Shaver by direct visualisation at the end of the hysteroscopic procedure and at post-operative ultrasound evaluation.
Measured: During surgery
Secondary outcomes (7)
Operation time
total operation time and time necessary for the morcellation
Measured: During surgery
Need for cervical dilation during procedure
Was it necessary to perform any dilatation with
Measured: During surgery
Volume of distension fluid used / loss (deficit) during procedure
Deficit in fluid used during surgery?
Measured: During surgery
Operator satisfaction, assessed by verbal rating scale
Operator satisfaction in terms of technique, ergonomics and general proceedings.
The verbal rating scale includes Very negative; Negative; Intermediate; Positive; Very positive.
Measured: At the end of the procedure
Complications
Adverse events during procedure/hospitalization and within the first 6 weeks after procedure
Measured: 6 weeks after surgery
Pain on the first postoperative day, assessed by verbal rating scale
Pain on the first day post-operatively. The verbal rating scale includes Very negative; Negative; Intermediate; Positive; Very positive.
Measured: Day 1 post-operatively
Histology of the intracavitary lesion
Incidence of histological outcomes such as endometrial polyps, intracavitary myomas or remnant products of conception.
This is a categorical variable.
Measured: 6 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start20 May 2021
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
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 Endometrial Polyp BenignStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811286
- Sponsor's protocol ID
- S64797
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share general descriptive characteristics of our cohort. This includes patient and operative characteristics, final histology and patient and doctor reported outcomes.
Publications
Munro MG, Christianson LA. Complications of Hysteroscopic and Uterine Resectoscopic Surgery. Clin Obstet Gynecol. 2015 Dec;58(4):765-97. doi: 10.1097/GRF.0000000000000146.
PubMed 26457853Shazly SA, Laughlin-Tommaso SK, Breitkopf DM, Hopkins MR, Burnett TL, Green IC, Farrell AM, Murad MH, Famuyide AO. Hysteroscopic Morcellation Versus Resection for the Treatment of Uterine Cavitary Lesions: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):867-77. doi: 10.1016/j.jmig.2016.04.013. Epub 2016 May 7.
PubMed 27164165Lee MM, Matsuzono T. Hysteroscopic intrauterine morcellation of submucosal fibroids: preliminary results in Hong Kong and comparisons with conventional hysteroscopic monopolar loop resection. Hong Kong Med J. 2016 Feb;22(1):56-61. doi: 10.12809/hkmj154600. Epub 2016 Jan 8.
PubMed 26744122Haber K, Hawkins E, Levie M, Chudnoff S. Hysteroscopic morcellation: review of the manufacturer and user facility device experience (MAUDE) database. J Minim Invasive Gynecol. 2015 Jan;22(1):110-4. doi: 10.1016/j.jmig.2014.08.008. Epub 2014 Aug 14.
PubMed 25128851Thubert T, Foulot H, Vinchant M, Santulli P, Marzouk P, Borghese B, Chapron C. Surgical treatment: Myomectomy and hysterectomy; Endoscopy: A major advancement. Best Pract Res Clin Obstet Gynaecol. 2016 Jul;34:104-21. doi: 10.1016/j.bpobgyn.2015.11.021. Epub 2016 Jun 22.
PubMed 27400649Pakrashi T. New hysteroscopic techniques for submucosal uterine fibroids. Curr Opin Obstet Gynecol. 2014 Aug;26(4):308-13. doi: 10.1097/GCO.0000000000000076.
PubMed 24950124Vidal-Mazo C, Forero-Diaz C, Lopez-Gonzalez E, Yera-Gilabert M, Machancoses FH. Clinical recurrence of submucosal myoma after a mechanical hysteroscopic myomectomy: Review after 5 years follow up. Eur J Obstet Gynecol Reprod Biol. 2019 Dec;243:41-45. doi: 10.1016/j.ejogrb.2019.10.014. Epub 2019 Oct 21.
PubMed 31671290van Dongen H, Emanuel MH, Wolterbeek R, Trimbos JB, Jansen FW. Hysteroscopic morcellator for removal of intrauterine polyps and myomas: a randomized controlled pilot study among residents in training. J Minim Invasive Gynecol. 2008 Jul-Aug;15(4):466-71. doi: 10.1016/j.jmig.2008.02.002. Epub 2008 Apr 18.
PubMed 18588849AlHilli MM, Nixon KE, Hopkins MR, Weaver AL, Laughlin-Tommaso SK, Famuyide AO. Long-term outcomes after intrauterine morcellation vs hysteroscopic resection of endometrial polyps. J Minim Invasive Gynecol. 2013 Mar-Apr;20(2):215-21. doi: 10.1016/j.jmig.2012.10.013. Epub 2013 Jan 5.
PubMed 23295201Li C, Dai Z, Gong Y, Xie B, Wang B. A systematic review and meta-analysis of randomized controlled trials comparing hysteroscopic morcellation with resectoscopy for patients with endometrial lesions. Int J Gynaecol Obstet. 2017 Jan;136(1):6-12. doi: 10.1002/ijgo.12012. Epub 2016 Nov 7.
PubMed 28099700Stoll F, Lecointre L, Meyer N, Faller E, Host A, Hummel M, Boisrame T, Akladios C, Garbin O. Randomized Study Comparing a Reusable Morcellator with a Resectoscope in the Hysteroscopic Treatment of Uterine Polyps: The RESMO Study. J Minim Invasive Gynecol. 2021 Apr;28(4):801-810. doi: 10.1016/j.jmig.2020.07.007. Epub 2020 Jul 16.
PubMed 32681995Ansari SH, Bigatti G, Aghssa MM. Operative hysteroscopy with the Bigatti shaver (IBS (R)) for the removal of placental remnants. Facts Views Vis Obgyn. 2018 Sep;10(3):153-159.
PubMed 31191850Bigatti G, Ansari SH, Di W. The 19 Fr. Intrauterine Bigatti Shaver (IBS(R)): a clinical and technical update. Facts Views Vis Obgyn. 2018 Sep;10(3):161-164.
PubMed 31191851
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Morcellator in Operative Hysteroscopy for Benign Intracavitary Lesions: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05811286
- Acronym / sponsor ID
- S64797
- Keywords
- Endometrial polyp, Hysteroscopic surgery, Morcellation, Retained products of conception, Myoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- 20 May 2021 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Polyps, intracavitary myomas and retained products of conception (RPOC) are common benign intracavitary lesions of the uterus and frequently cause abnormal uterine bleeding or pain. In general, intracavitary lesions are treated by operative hysteroscopy with bipolar resectoscopic removal under general anaesthesia, performed in the theatre (OR). Potential problems with this approach are thermal damage and impairment of visibility due to loose tissue fragments necessitating multiple entries for tissue removal.
Recently, lesion morcellation by hysteroscopy has been introduced as an alternative technique. Compared to the resectoscopic approach, morcellation is reportedly associated with a shorter total procedure time, smaller fluid deficit and number of insertions. A few trials also registered a higher success rate in completeness of resection.
No significant differences in odds of surgical complications have been reported.
Most hysteroscopic morcellators have diameters up to 8 mm, for which cervical dilation under general anaesthesia is usually needed.
Recently, companies have developed hysteroscopic morcellators with smaller diameters, e.g. 6.3 mm for the 19 Fr. intrauterine BIGATTI Shaver (IBS®). This means less need for cervical dilation, and potential use without anesthesia.
At this moment, there are no prospective studies available on feasibility of the 19 Fr. intrauterine BIGATTI Shaver (IBS®). Before implementing hysteroscopic morcellation in our department, we need a feasibility study assessing the method in standard conditions in the operation room or in ambulatory setting under sedation.
Trial objectives:
Assessment of the feasibility of hysteroscopic morcellation of benign uterine intracavitary lesions. The primary objective is to assess the completeness of hysteroscopic resection in patients undergoing the procedure under general anesthesia or sedation.
Secondary objectives are to assess perioperative parameters as operation time, need for cervical dilation, adverse events, pain, operator satisfaction; to assess quality of tissue for histological examination; to assess postoperative complications and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions | Experimental | Procedure: Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesionsSingle experimental arm of patients with a intracavitary lesion and elligible for hysteroscopic morcellation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients:
- Ultrasonographic diagnosis of an intracavitary lesion, according the IETA terms and definitions
- endometrial polyp
- FIGO 0-1 myoma (maximum diameter 2 cm)
- RPOC (maximum diameter 2 cm, no enhanced myometrial vascularity)
Key exclusion criteria (7 listed)
- • Active vaginal bleeding
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 |
|---|---|---|
| Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesionsWith the shaver, the lesion is removed in the OR. We will include endometrial polyps, FIGO 0-1 myomas and retained products of conception. We will assess the completeness of hysteroscopic resection, operation time, need for cervical dilation, adverse events, pain, operator satisfaction; quality of tissue for histological examination, postoperative complications and pain. | Procedure or surgery | Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions |
Primary outcome
Completeness of resection of intracavitary lesions in 50 patients, when using a hysteroscopic Bigatti Shaver.
Time frame: During surgery
If all tissue could be removed by the 19 Fr. intrauterine BIGATTI Shaver by direct visualisation at the end of the hysteroscopic procedure and at post-operative ultrasound evaluation.
7 secondary outcomes
Operation time
Time frame: During surgery
Need for cervical dilation during procedure
Time frame: During surgery
Volume of distension fluid used / loss (deficit) during procedure
Time frame: During surgery
Operator satisfaction, assessed by verbal rating scale
Time frame: At the end of the procedure
Complications
Time frame: 6 weeks after surgery
Pain on the first postoperative day, assessed by verbal rating scale
Time frame: Day 1 post-operatively
Histology of the intracavitary lesion
Time frame: 6 weeks post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Background: PubMed 26457853Munro MG, Christianson LA. Complications of Hysteroscopic and Uterine Resectoscopic Surgery. Clin Obstet Gynecol. 2015 Dec;58(4):765-97. doi: 10.1097/GRF.0000000000000146.
- Background: PubMed 27164165Shazly SA, Laughlin-Tommaso SK, Breitkopf DM, Hopkins MR, Burnett TL, Green IC, Farrell AM, Murad MH, Famuyide AO. Hysteroscopic Morcellation Versus Resection for the Treatment of Uterine Cavitary Lesions: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):867-77. doi: 10.1016/j.jmig.2016.04.013. Epub 2016 May 7.
- Background: PubMed 26744122Lee MM, Matsuzono T. Hysteroscopic intrauterine morcellation of submucosal fibroids: preliminary results in Hong Kong and comparisons with conventional hysteroscopic monopolar loop resection. Hong Kong Med J. 2016 Feb;22(1):56-61. doi: 10.12809/hkmj154600. Epub 2016 Jan 8.
- Background: PubMed 25128851Haber K, Hawkins E, Levie M, Chudnoff S. Hysteroscopic morcellation: review of the manufacturer and user facility device experience (MAUDE) database. J Minim Invasive Gynecol. 2015 Jan;22(1):110-4. doi: 10.1016/j.jmig.2014.08.008. Epub 2014 Aug 14.
- Background: PubMed 27400649Thubert T, Foulot H, Vinchant M, Santulli P, Marzouk P, Borghese B, Chapron C. Surgical treatment: Myomectomy and hysterectomy; Endoscopy: A major advancement. Best Pract Res Clin Obstet Gynaecol. 2016 Jul;34:104-21. doi: 10.1016/j.bpobgyn.2015.11.021. Epub 2016 Jun 22.
- Background: PubMed 24950124Pakrashi T. New hysteroscopic techniques for submucosal uterine fibroids. Curr Opin Obstet Gynecol. 2014 Aug;26(4):308-13. doi: 10.1097/GCO.0000000000000076.
- Background: PubMed 31671290Vidal-Mazo C, Forero-Diaz C, Lopez-Gonzalez E, Yera-Gilabert M, Machancoses FH. Clinical recurrence of submucosal myoma after a mechanical hysteroscopic myomectomy: Review after 5 years follow up. Eur J Obstet Gynecol Reprod Biol. 2019 Dec;243:41-45. doi: 10.1016/j.ejogrb.2019.10.014. Epub 2019 Oct 21.
- Background: PubMed 18588849van Dongen H, Emanuel MH, Wolterbeek R, Trimbos JB, Jansen FW. Hysteroscopic morcellator for removal of intrauterine polyps and myomas: a randomized controlled pilot study among residents in training. J Minim Invasive Gynecol. 2008 Jul-Aug;15(4):466-71. doi: 10.1016/j.jmig.2008.02.002. Epub 2008 Apr 18.
- Background: PubMed 23295201AlHilli MM, Nixon KE, Hopkins MR, Weaver AL, Laughlin-Tommaso SK, Famuyide AO. Long-term outcomes after intrauterine morcellation vs hysteroscopic resection of endometrial polyps. J Minim Invasive Gynecol. 2013 Mar-Apr;20(2):215-21. doi: 10.1016/j.jmig.2012.10.013. Epub 2013 Jan 5.
- Background: PubMed 28099700Li C, Dai Z, Gong Y, Xie B, Wang B. A systematic review and meta-analysis of randomized controlled trials comparing hysteroscopic morcellation with resectoscopy for patients with endometrial lesions. Int J Gynaecol Obstet. 2017 Jan;136(1):6-12. doi: 10.1002/ijgo.12012. Epub 2016 Nov 7.
- Background: PubMed 32681995Stoll F, Lecointre L, Meyer N, Faller E, Host A, Hummel M, Boisrame T, Akladios C, Garbin O. Randomized Study Comparing a Reusable Morcellator with a Resectoscope in the Hysteroscopic Treatment of Uterine Polyps: The RESMO Study. J Minim Invasive Gynecol. 2021 Apr;28(4):801-810. doi: 10.1016/j.jmig.2020.07.007. Epub 2020 Jul 16.
- Background: PubMed 31191850Ansari SH, Bigatti G, Aghssa MM. Operative hysteroscopy with the Bigatti shaver (IBS (R)) for the removal of placental remnants. Facts Views Vis Obgyn. 2018 Sep;10(3):153-159.
- Individual participant dataSharing planned: No. We will share general descriptive characteristics of our cohort. This includes patient and operative characteristics, final histology and patient and doctor reported outcomes.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions in people with Endometrial Polyp Benign and Retained Products of Conception, run by Universitaire Ziekenhuizen KU Leuven at 2 sites 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Completeness of resection of intracavitary lesions in 50 patients, when using a hysteroscopic Bigatti Shaver. (time frame: During surgery). 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 NCT05811286, 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 14 Jul 2023.