Neoplasms,ColorectalPATENCYNCT05643989
Self-expandable Metal Stent (SEMS) Endoscopic Placement for Malignant Colonic Obstruction Therapy
A study testing Stoma formation and Endoscopic self-expandable metal stent placement in people with Neoplasms,Colorectal, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
Trial summary
Compare the effectiveness of Self-expandable metal stent (SEMS) and diverting stoma formation for the bowel preparation as a bridge to surgical treatment of patients with MCO. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Neoplasms,Colorectal
- What is being tested?
- Stoma formation and Endoscopic self-expandable metal stent placement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2019to 11 May 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are 18 years old or older
- Stage I-IV according to TNM classification
- Patients with malignant colonic obstruction
- Overall health status according to ASA classification: I-III
- Overall health status according to Charlson comorbidity index ≤ 8 points
- Signed informed consent with agreement to attend all study visits
- The patient is not pregnant
Who cannot join
- Inflammatory bowel disease
- Acute purulent process in the abdominal cavity
- The patient wants to withdraw from the clinical trial
- Loss to follow-up
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Clinic of colorectal and minimally invasive surgery University Hospital n2, Clinical Center Sechenov First Moscow State Medical University
Moscow
Gorovaia Irina, 007-917-599-84-59, rudenko@kkmx.ru
Tsarkov Petr, professor, 007-499-110-32-22, tsarkov@kkmx.ru
About this study
Official title: Randomized Non-inferiority Single-center Prospective Trial of Malignant Colonic Obstruction Therapy With Self-expandable Metal Stent (SEMS) Endoscopic Placement or Stoma Formation.
Compare the effectiveness of Self-expandable metal stent (SEMS) and diverting stoma formation for the bowel preparation as a bridge to surgical treatment of patients with MCO.
Read the detailed description
Surgical treatment of MCO is associated with high mortality and frequent development of postoperative complications. Stoma formation is the traditional method of urgent treatment of MCO. Currently there are more than 150 methods of colorectal stomas formation, but all of themare associated with a high risk of complications (10-20%), inclusively both early and late postoperative period. It results in longerhospital stay and requires additional financial expenses, also reoperations can be fatal for patients.
Analysis of recent publications devoted to the treatment of MCO shows increasing implemented of new strategies of patents management, such as "fast track surgery", or "fast track recovery strategy" in clinical practice. Minimally invasive endoscopic procedures as a first stage of MCO treatment leads to transformation of previously performed multi-stage surgical interventions into one - stage.
Development of up-to-date endoscopic science and technology provides a wide usage ofself-expandable metal stent (SEMS) in clinical practice. This strategy helps to avoid stoma formation or emergency surgery, becoming a "bridge" to a radical surgery.
There are currently no studies directly comparing discharge stoma with endoscopic self-expandable metal stenting in preparation for colorectal cancer radical surgery.
- Conditions
- Neoplasms,Colorectal
- Being tested
- Stoma formation, Endoscopic self-expandable metal stent placement
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stoma formationProcedure or surgery
Trocar placement: the optical trocar (10 mm) will be inserted just near umbilicus . An abdominal revision is performed to determine the location of the tumor. Colon in 10 sm proximally to tumor is prepared for the discharge stoma formation. In the corresponding location on the anterior abdominal wall is formed incision of skin and subcutaneous tissue to the aponeurosis, the cut length is 2.5 sm. After that, aponeurosis crucial incision is performed. The previously prepared colon is brought out to the anterior abdominal wall with the help of a grasper. Discharge stoma is attached to a holding device; colon is fixed by the interrupted sutures (Polysorb 3-0). In the operating room, the stoma is opened, the intestinal patency is checked in both directions, and hemostasis is revealed. With the help of optics, the presence of intestinal tension is checked; if necessary, the colon is additionally mobilized.
Endoscopic self-expandable metal stent placementProcedure or surgery
The colonoscope is passed to the distal edge of the tumor and a biopsy of the tumor is performed (if the tumor has not previously been verified). Through the tumor stenosis radioscopically guided metal conductor with atraumatic distal end installs in the proximal colon. A covered or partially covered metal self- expanding stent is placed in the area of tumor stenosis by the conductor, symmetrically in relation to the area of tumor stenosis. Radioscopically and endoscopically guided disclosure of a SEMS is performed immediately after which there is an abundant discharge of gases and intestinal contents. Upon completion of the procedure, the patient is transferred to the patient's room. The next day, a control X-ray of the abdomen is taken.
| Study group | Role | What they receive |
|---|---|---|
| Self-expandable metal stent (SEMS) endoscopic placement. | Active comparator | Anesthesia will include only propofol injection. A covered or partially covered metal self- expanding stent is placed in the area of tumor stenosis by the conductor, symmetrically in relation to the area of tumor stenosis. Receives: Procedure: Endoscopic self-expandable metal stent placement |
| Stoma formation. | Placebo comparator | Anesthetic care will include general endotracheal anesthesia with positioning of nasogastric tube and bladder catheterization. The diverting stoma formation will be proceed in 10 sm proximally to tumor. Receives: Procedure: Stoma formation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel preparation (absence of feaces) according to Boston Bowel Preparation Scale
Evaluated via colonoscopy in colon and rectum distal to the tumour. Total score of bowel preparation measured from 0 to 9. The maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0. This is evaluated by the endoscopist
Measured: on the 3rd day after obstruction treatment (SEMS or stoma formation)
Secondary outcomes (11)
Intraoperative complications rate during stoma formation or stent placement
The rate of complications during the procedure
Measured: 1 day (the day of procedure)
Early postoperative complications rate after stoma formation or stent placement
The rate of complications after the procedure
Measured: up to 7 days after procedure
Length of hospital stay after stoma formation or stent placement
Number of days spent in hospital after procedure
Measured: 30 days after procedure
Quality of life before and after stoma formation or stent placement
Measured by patient-reported SF-36 scale before and after procedure
Measured: -1 day (before procedure), 3rd and 7th day after procedure
Operation time of resectional surgery
The duration of surgical procedure in minutes
Measured: 1 day (the day of tumor resection surgery )
Stoma formation rate
The percentage of patients who had preventive or definitive stoma during resectional surgery in the SEMS group
Measured: 1 day (the day of tumor resection surgery )
Stoma reversal rate
The rate of previously formed stoma reversal simultaneously with tumor resection
Measured: 1 day (the day of tumor resection surgery )
Early postoperative complications rate after resectional surgery
The rate complications after tumor resection surgery
Measured: 30 days after resectional surgery
Length of hospital stay after resectional surgery
Number of days spent in hospital after tumor resection surgery
Measured: 30 days after resectional surgery
Intraoperative complications rate during resectional surgery
The rate of complications during tumor resection surgery
Measured: 1 day (the day of resectional surgery)
Late complications rate during resectional surgery
The rate of complications after tumor resection surgery
Measured: 31-90 days after tumor resection surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Nov 2019
- Primary completion1 Feb 2023 (estimated)
- Study completion11 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Neoplasms,ColorectalStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Society of Colorectal Surgeons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petr Tsarkov, Prof, Principal investigator, Russian Society of Colorectal Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643989
- Sponsor's protocol ID
- 34-20
- Acronym
- PATENCY
- Status last verified
- Dec 2022
- First submitted
- 10 Jun 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cronin KA, Lake AJ, Scott S, Sherman RL, Noone AM, Howlader N, Henley SJ, Anderson RN, Firth AU, Ma J, Kohler BA, Jemal A. Annual Report to the Nation on the Status of Cancer, part I: National cancer statistics. Cancer. 2018 Jul 1;124(13):2785-2800. doi: 10.1002/cncr.31551. Epub 2018 May 22.
PubMed 29786848Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
PubMed 21296855Cheynel N, Cortet M, Lepage C, Benoit L, Faivre J, Bouvier AM. Trends in frequency and management of obstructing colorectal cancers in a well-defined population. Dis Colon Rectum. 2007 Oct;50(10):1568-75. doi: 10.1007/s10350-007-9007-4.
PubMed 17687610Baron TH. Colonic stenting: a palliative measure only or a bridge to surgery? Endoscopy. 2010 Feb;42(2):163-8. doi: 10.1055/s-0029-1243881. Epub 2010 Feb 5.
PubMed 20140833Larkin JO, Moriarity AR, Cooke F, McCormick PH, Mehigan BJ. Self-expanding metal stent insertion by colorectal surgeons in the management of obstructing colorectal cancers: a 6-year experience. Tech Coloproctol. 2014 May;18(5):453-8. doi: 10.1007/s10151-013-1073-0. Epub 2013 Oct 10.
PubMed 24114608Kim EJ, Kim YJ. Stents for colorectal obstruction: Past, present, and future. World J Gastroenterol. 2016 Jan 14;22(2):842-52. doi: 10.3748/wjg.v22.i2.842.
PubMed 26811630Maleckis K, Anttila E, Aylward P, Poulson W, Desyatova A, MacTaggart J, Kamenskiy A. Nitinol Stents in the Femoropopliteal Artery: A Mechanical Perspective on Material, Design, and Performance. Ann Biomed Eng. 2018 May;46(5):684-704. doi: 10.1007/s10439-018-1990-1. Epub 2018 Feb 22.
PubMed 29470746Nakata K, Fukunaga M, Ebihara T, Kato F, Amano K, Babaya A, Matsushita A, Furukawa H, Matsushima Y, Matsumoto H, Fujihara S, Kawabata R, Usui A, Yamamoto T, Oda K, Kawase T, Kimura Y, Nakata Y, Ohzato H. [A study of laparoscopic stoma creation for patients with malignant bowel obstruction]. Gan To Kagaku Ryoho. 2013 Nov;40(12):1702-4. Japanese.
PubMed 24393894van den Berg MW, Ledeboer M, Dijkgraaf MG, Fockens P, ter Borg F, van Hooft JE. Long-term results of palliative stent placement for acute malignant colonic obstruction. Surg Endosc. 2015 Jun;29(6):1580-5. doi: 10.1007/s00464-014-3845-7. Epub 2014 Oct 8.
PubMed 25294532Kim YW, Kim IY. The Role of Surgery for Asymptomatic Primary Tumors in Unresectable Stage IV Colorectal Cancer. Ann Coloproctol. 2013 Apr;29(2):44-54. doi: 10.3393/ac.2013.29.2.44. Epub 2013 Apr 30.
PubMed 23700570
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Non-inferiority Single-center Prospective Trial of Malignant Colonic Obstruction Therapy With Self-expandable Metal Stent (SEMS) Endoscopic Placement or Stoma Formation.
- ClinicalTrials.gov ID
- NCT05643989
- Acronym / sponsor ID
- PATENCY / 34-20
- Conditions
- Neoplasms,Colorectal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Russian Society of Colorectal SurgeonsUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 11 May 2023 (estimated)
- First posted
- 9 Dec 2022 (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.
Compare the effectiveness of Self-expandable metal stent (SEMS) and diverting stoma formation for the bowel preparation as a bridge to surgical treatment of patients with MCO.
Detailed description
Surgical treatment of MCO is associated with high mortality and frequent development of postoperative complications. Stoma formation is the traditional method of urgent treatment of MCO. Currently there are more than 150 methods of colorectal stomas formation, but all of themare associated with a high risk of complications (10-20%), inclusively both early and late postoperative period. It results in longerhospital stay and requires additional financial expenses, also reoperations can be fatal for patients.
Analysis of recent publications devoted to the treatment of MCO shows increasing implemented of new strategies of patents management, such as "fast track surgery", or "fast track recovery strategy" in clinical practice. Minimally invasive endoscopic procedures as a first stage of MCO treatment leads to transformation of previously performed multi-stage surgical interventions into one - stage.
Development of up-to-date endoscopic science and technology provides a wide usage ofself-expandable metal stent (SEMS) in clinical practice. This strategy helps to avoid stoma formation or emergency surgery, becoming a "bridge" to a radical surgery.
There are currently no studies directly comparing discharge stoma with endoscopic self-expandable metal stenting in preparation for colorectal cancer radical surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-expandable metal stent (SEMS) endoscopic placement. | Active comparator | Procedure: Endoscopic self-expandable metal stent placementAnesthesia will include only propofol injection. A covered or partially covered metal self- expanding stent is placed in the area of tumor stenosis by the conductor, symmetrically in relation to the area of tumor stenosis. |
| Stoma formation. | Placebo comparator | Procedure: Stoma formationAnesthetic care will include general endotracheal anesthesia with positioning of nasogastric tube and bladder catheterization. The diverting stoma formation will be proceed in 10 sm proximally to tumor. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients are 18 years old or older
- Stage I-IV according to TNM classification
- Patients with malignant colonic obstruction
- Overall health status according to ASA classification: I-III
- Overall health status according to Charlson comorbidity index ≤ 8 points
Key exclusion criteria (4 listed)
- Inflammatory bowel disease
- Acute purulent process in the abdominal cavity
- The patient wants to withdraw from the clinical trial
- Loss to follow-up
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 |
|---|---|---|
| Stoma formationTrocar placement: the optical trocar (10 mm) will be inserted just near umbilicus . An abdominal revision is performed to determine the location of the tumor. Colon in 10 sm proximally to tumor is prepared for the discharge stoma formation. In the corresponding location on the anterior abdominal wall is formed incision of skin and subcutaneous tissue to the aponeurosis, the cut length is 2.5 sm. After that, aponeurosis crucial incision is performed. The previously prepared colon is brought out to the anterior abdominal wall with the help of a grasper. Discharge stoma is attached to a holding device; colon is fixed by the interrupted sutures (Polysorb 3-0). In the operating room, the stoma is opened, the intestinal patency is checked in both directions, and hemostasis is revealed. With the help of optics, the presence of intestinal tension is checked; if necessary, the colon is additionally mobilized. | Procedure or surgery | Stoma formation. |
| Endoscopic self-expandable metal stent placementThe colonoscope is passed to the distal edge of the tumor and a biopsy of the tumor is performed (if the tumor has not previously been verified). Through the tumor stenosis radioscopically guided metal conductor with atraumatic distal end installs in the proximal colon. A covered or partially covered metal self- expanding stent is placed in the area of tumor stenosis by the conductor, symmetrically in relation to the area of tumor stenosis. Radioscopically and endoscopically guided disclosure of a SEMS is performed immediately after which there is an abundant discharge of gases and intestinal contents. Upon completion of the procedure, the patient is transferred to the patient's room. The next day, a control X-ray of the abdomen is taken. | Procedure or surgery | Self-expandable metal stent (SEMS) endoscopic placement. |
Primary outcome
Bowel preparation (absence of feaces) according to Boston Bowel Preparation Scale
Time frame: on the 3rd day after obstruction treatment (SEMS or stoma formation)
Evaluated via colonoscopy in colon and rectum distal to the tumour. Total score of bowel preparation measured from 0 to 9. The maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0. This is evaluated by the endoscopist
11 secondary outcomes
Intraoperative complications rate during stoma formation or stent placement
Time frame: 1 day (the day of procedure)
Early postoperative complications rate after stoma formation or stent placement
Time frame: up to 7 days after procedure
Length of hospital stay after stoma formation or stent placement
Time frame: 30 days after procedure
Quality of life before and after stoma formation or stent placement
Time frame: -1 day (before procedure), 3rd and 7th day after procedure
Operation time of resectional surgery
Time frame: 1 day (the day of tumor resection surgery )
Stoma formation rate
Time frame: 1 day (the day of tumor resection surgery )
Stoma reversal rate
Time frame: 1 day (the day of tumor resection surgery )
Early postoperative complications rate after resectional surgery
Time frame: 30 days after resectional surgery
Length of hospital stay after resectional surgery
Time frame: 30 days after resectional surgery
Intraoperative complications rate during resectional surgery
Time frame: 1 day (the day of resectional surgery)
Late complications rate during resectional surgery
Time frame: 31-90 days after tumor resection surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Background: PubMed 29786848Cronin KA, Lake AJ, Scott S, Sherman RL, Noone AM, Howlader N, Henley SJ, Anderson RN, Firth AU, Ma J, Kohler BA, Jemal A. Annual Report to the Nation on the Status of Cancer, part I: National cancer statistics. Cancer. 2018 Jul 1;124(13):2785-2800. doi: 10.1002/cncr.31551. Epub 2018 May 22.
- Background: PubMed 21296855Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
- Background: PubMed 17687610Cheynel N, Cortet M, Lepage C, Benoit L, Faivre J, Bouvier AM. Trends in frequency and management of obstructing colorectal cancers in a well-defined population. Dis Colon Rectum. 2007 Oct;50(10):1568-75. doi: 10.1007/s10350-007-9007-4.
- Background: PubMed 20140833Baron TH. Colonic stenting: a palliative measure only or a bridge to surgery? Endoscopy. 2010 Feb;42(2):163-8. doi: 10.1055/s-0029-1243881. Epub 2010 Feb 5.
- Background: PubMed 24114608Larkin JO, Moriarity AR, Cooke F, McCormick PH, Mehigan BJ. Self-expanding metal stent insertion by colorectal surgeons in the management of obstructing colorectal cancers: a 6-year experience. Tech Coloproctol. 2014 May;18(5):453-8. doi: 10.1007/s10151-013-1073-0. Epub 2013 Oct 10.
- Background: PubMed 26811630Kim EJ, Kim YJ. Stents for colorectal obstruction: Past, present, and future. World J Gastroenterol. 2016 Jan 14;22(2):842-52. doi: 10.3748/wjg.v22.i2.842.
- Background: PubMed 29470746Maleckis K, Anttila E, Aylward P, Poulson W, Desyatova A, MacTaggart J, Kamenskiy A. Nitinol Stents in the Femoropopliteal Artery: A Mechanical Perspective on Material, Design, and Performance. Ann Biomed Eng. 2018 May;46(5):684-704. doi: 10.1007/s10439-018-1990-1. Epub 2018 Feb 22.
- Background: PubMed 24393894Nakata K, Fukunaga M, Ebihara T, Kato F, Amano K, Babaya A, Matsushita A, Furukawa H, Matsushima Y, Matsumoto H, Fujihara S, Kawabata R, Usui A, Yamamoto T, Oda K, Kawase T, Kimura Y, Nakata Y, Ohzato H. [A study of laparoscopic stoma creation for patients with malignant bowel obstruction]. Gan To Kagaku Ryoho. 2013 Nov;40(12):1702-4. Japanese.
- Background: PubMed 25294532van den Berg MW, Ledeboer M, Dijkgraaf MG, Fockens P, ter Borg F, van Hooft JE. Long-term results of palliative stent placement for acute malignant colonic obstruction. Surg Endosc. 2015 Jun;29(6):1580-5. doi: 10.1007/s00464-014-3845-7. Epub 2014 Oct 8.
- Results publication: PubMed 23700570Kim YW, Kim IY. The Role of Surgery for Asymptomatic Primary Tumors in Unresectable Stage IV Colorectal Cancer. Ann Coloproctol. 2013 Apr;29(2):44-54. doi: 10.3393/ac.2013.29.2.44. Epub 2013 Apr 30.
- 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.
Petr Tsarkov, Prof principal investigator
Russian Society of Colorectal Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stoma formation and Endoscopic self-expandable metal stent placement in people with Neoplasms,Colorectal, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
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 4 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 9 Dec 2022. 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 Russia. 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. Some participants in this study may receive a placebo. 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?
Contact Irina Gorovaia, MD (+79175998459, rudenko@kkmx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel preparation (absence of feaces) according to Boston Bowel Preparation Scale (time frame: on the 3rd day after obstruction treatment (SEMS or stoma formation)). 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 NCT05643989, which also lists 10 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 9 Dec 2022.