Colorectal NeoplasmsAP-NOSESNCT07615036
AP-NOSES: A Prospective Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery
An observational study of Colorectal Neoplasms and Incisional Hernia, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Natural orifice specimen extraction (NOSE) is a minimally invasive colorectal surgical technique in which the surgical specimen is removed through a natural orifice, including transanal or transvaginal routes, thereby avoiding an abdominal extraction incision. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Colorectal Neoplasms, Incisional Hernia
- What is being tested?
- Natural Orifice Specimen Extraction and Transabdominal Specimen Extraction
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteSingapore
- Study dates
- 5 May 2026to 30 Dec 2033
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective minimally invasive colorectal resection with planned intact specimen extraction at participating tertiary colorectal centers in the Asia-Pacific region.
Who may be able to join
- Age 21 years or older
- Elective minimally invasive colorectal resection (laparoscopic or robotic intent)
- Planned intact specimen extraction
- Eligible for natural orifice specimen extraction (NOSE) or transabdominal specimen extraction according to study protocol
- Ability to provide informed consent
Who cannot join
- Emergency colorectal surgery
- Planned transanal total mesorectal excision (TaTME)
- Planned ultralow anterior resection with planned anastomosis 3 cm or less from the anal verge
- Planned abdominoperineal resection (APR)
- Planned permanent end stoma without restoration of intestinal continuity
- Planned multivisceral resection
Show all 11Show fewer
- Generalized peritonitis or uncontrolled intra-abdominal sepsis
- Pregnancy
- Pre-existing ventral or incisional hernia at the planned extraction site
- Planned specimen extraction through a prior laparotomy incision containing mesh
- Fixed distal obstruction, severe pelvic stenosis, or other anatomical constraint precluding intact specimen extraction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169608
Isaac Seow-En, MBBS, FRCSEd, +6563213853, isaac.seow.en@singhealth.com.sg
About this study
Official title: AP-NOSES: A Prospective, Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery Across the Asia-Pacific Region
Natural orifice specimen extraction (NOSE) is a minimally invasive colorectal surgical technique in which the surgical specimen is removed through a natural orifice, including transanal or transvaginal routes, thereby avoiding an abdominal extraction incision. Observational studies suggest that NOSE may reduce wound-related morbidity and improve postoperative recovery, but prospective multicenter data evaluating long-term outcomes remain limited.
AP-NOSES is a prospective, multicenter observational registry evaluating clinical, patient-reported, and long-term wound outcomes following minimally invasive colorectal surgery with NOSE or transabdominal specimen extraction. The primary objective is to compare time to incisional hernia within 24 months between NOSE-eligible patients undergoing planned NOSE extraction and NOSE-eligible patients undergoing planned transabdominal extraction.
Read more
Secondary objectives include evaluation of postoperative complications, extraction-related morbidity, bowel function, urinary and sexual function, oncologic outcomes, and long-term patient-reported and clinical outcomes across participating centers.
This study does not alter routine clinical care. Surgical technique, perioperative management, and follow-up are performed according to local institutional practice.
Read the detailed description
Natural orifice specimen extraction (NOSE) is an established minimally invasive colorectal surgical technique that enables removal of the surgical specimen through transanal or transvaginal routes while avoiding an abdominal specimen extraction incision. Existing retrospective studies and meta-analyses suggest that NOSE may reduce postoperative pain, wound morbidity, and length of hospital stay without compromising oncologic outcomes. However, prospective multicenter data evaluating long-term abdominal wall outcomes and patient-reported outcomes remain limited.
Incisional hernia is a common long-term complication following colorectal surgery and is closely associated with the abdominal extraction site. By avoiding an abdominal extraction incision, NOSE may reduce extraction-site morbidity and long-term incisional hernia risk. AP-NOSES was designed to prospectively evaluate these outcomes in a multicenter setting using predefined eligibility criteria and a concurrent comparator cohort.
AP-NOSES is a prospective observational multicenter registry coordinated by Singapore General Hospital. Consecutive adult patients undergoing elective minimally invasive colorectal resection with planned intact specimen extraction are eligible for enrollment. Participating centers include tertiary colorectal units within the Asia-Pacific region.
The primary comparative analysis is conducted within a predefined NOSE-eligible cohort. Exposure groups are defined according to planned specimen extraction strategy:
- Planned NOSE extraction (transanal or transvaginal), and
- Planned transabdominal extraction among patients meeting protocol NOSE eligibility criteria.
Planned and achieved extraction routes, reasons for non-performance of NOSE, operative details, postoperative complications, and oncologic outcomes are prospectively recorded.
The primary outcome is time to incisional hernia within 24 months following index colorectal surgery.
Secondary outcomes include postoperative complications, extraction-site morbidity, surgical site infection, readmission, reoperation, pathologic outcomes, patient-reported quality-of-life and functional outcomes, bowel function, urinary and sexual function in selected patients, and oncologic outcomes including recurrence and disease-free survival.
Patient-reported outcomes are assessed using validated instruments including EQ-5D-5L, Body Image Scale (BIS), Low Anterior Resection Syndrome (LARS) score, International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), and Female Sexual Function Index-6 (FSFI-6), where applicable.
This study is observational and does not mandate changes to standard surgical or postoperative management. Data are entered into a secure centralized REDCap database using coded study identifiers.
- Conditions
- Colorectal Neoplasms, Incisional Hernia
- Being tested
- Natural Orifice Specimen Extraction, Transabdominal Specimen Extraction
- Keywords
- Natural Orifice Specimen Extraction, NOSE surgery, Minimally invasive colorectal surgery, Incisional hernia, Laparoscopic colorectal surgery, Transanal specimen extraction, Transvaginal specimen extraction, Patient-reported outcomes, Prospective registry
- Medical subject headings
- Colorectal Neoplasms, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Orifice Specimen ExtractionProcedure or surgery
Specimen extraction through a natural orifice, including transanal or transvaginal extraction, during minimally invasive colorectal surgery.
Transabdominal Specimen ExtractionProcedure or surgery
Specimen extraction through an abdominal incision during minimally invasive colorectal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Planned NOSE Extraction | Patients undergoing planned natural orifice specimen extraction (NOSE), including transanal or transvaginal extraction, during elective minimally invasive colorectal surgery. Receives: Procedure: Natural Orifice Specimen Extraction | |
| Planned Transabdominal Extraction | NOSE-eligible patients undergoing planned transabdominal specimen extraction during elective minimally invasive colorectal surgery. Receives: Procedure: Transabdominal Specimen Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Incisional Hernia Within 24 Months
Time from index colorectal surgery to first clinical or radiologic diagnosis of incisional hernia at or adjacent to the specimen extraction site.
Measured: 24 months after index surgery
Secondary outcomes (10)
Overall Postoperative Complications
Postoperative complications within 30 days classified according to the Clavien-Dindo grading system.
Measured: 30 days after surgery
Surgical Site Infection
Incidence of postoperative surgical site infection following minimally invasive colorectal surgery.
Measured: 30 days after surgery
Extraction-Site Complications
Extraction-related morbidity including specimen rupture, contamination, bleeding, fistula, or extraction-site injury.
Measured: 30 days after surgery
Length of Hospital Stay
Length of postoperative inpatient hospital stay following index colorectal surgery.
Measured: From date of surgery until hospital discharge, up to 30 days
EQ-5D-5L Score
Health-related quality-of-life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire.
Measured: Baseline, 6 months, and 12 months after surgery
Body Image Scale (BIS) Score
Body image assessed using the Body Image Scale (BIS).
Measured: Baseline, 6 months, and 12 months after surgery
Low Anterior Resection Syndrome (LARS) Score
Bowel function assessed using the Low Anterior Resection Syndrome (LARS) score.
Measured: 6 months and 12 months after surgery
Local Recurrence
Incidence of local recurrence following minimally invasive colorectal surgery.
Measured: Up to 24 months after surgery
Distant Recurrence
Incidence of distant recurrence following minimally invasive colorectal surgery.
Measured: Up to 24 months after surgery
Disease-Free Survival
Time from index colorectal surgery to recurrence or death from any cause.
Measured: Up to 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start5 May 2026
- Primary completion30 Mar 2033 (estimated)
- Study completion30 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isaac Seow En, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615036
- Sponsor's protocol ID
- 2026-0237
- Acronym
- AP-NOSES
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data sharing plans have not yet been finalized. Future sharing of deidentified data may be considered following establishment of multicenter governance, data-sharing agreements, and publication policies.
Publications
den Hartog FPJ, van Egmond S, Poelman MM, Menon AG, Kleinrensink GJ, Lange JF, Tanis PJ, Deerenberg EB. The incidence of extraction site incisional hernia after minimally invasive colorectal surgery: a systematic review and meta-analysis. Colorectal Dis. 2023 Apr;25(4):586-599. doi: 10.1111/codi.16455. Epub 2023 Jan 5.
PubMed 36545836Chin YH, Decruz GM, Ng CH, Tan HQM, Lim F, Foo FJ, Tai CH, Chong CS. Colorectal resection via natural orifice specimen extraction versus conventional laparoscopic extraction: a meta-analysis with meta-regression. Tech Coloproctol. 2021 Jan;25(1):35-48. doi: 10.1007/s10151-020-02330-6. Epub 2020 Aug 26.
PubMed 32851500Guan X, Liu Z, Longo A, Cai JC, Tzu-Liang Chen W, Chen LC, Chun HK, Manuel da Costa Pereira J, Efetov S, Escalante R, He QS, Hu JH, Kayaalp C, Kim SH, Khan JS, Kuo LJ, Nishimura A, Nogueira F, Okuda J, Saklani A, Shafik AA, Shen MY, Son JT, Song JM, Sun DH, Uehara K, Wang GY, Wei Y, Xiong ZG, Yao HL, Yu G, Yu SJ, Zhou HT, Lee SH, Tsarkov PV, Fu CG, Wang XS; International Alliance of NOSES. International consensus on natural orifice specimen extraction surgery (NOSES) for colorectal cancer. Gastroenterol Rep (Oxf). 2019 Feb;7(1):24-31. doi: 10.1093/gastro/goy055. Epub 2019 Jan 23.
PubMed 30792863Seow-En I, Wong KY, Koo CH, Khor SN, Fu CWP, Chang M, Tan MNA, Kitaguchi D, Ng ZQ, Shao YC, Shen MY, Chang SC, Chen WT; AP-NOSES Collaborative. Prospective multicentre observational study of natural orifice specimen extraction in minimally invasive colorectal surgery in the Asia-Pacific: protocol for the AP-NOSES registry. BMJ Open. 2026 Sep 18;16(9):e123140. doi: 10.1136/bmjopen-2026-123140.
PubMed 42760090
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AP-NOSES: A Prospective, Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery Across the Asia-Pacific Region
- ClinicalTrials.gov ID
- NCT07615036
- Acronym / sponsor ID
- AP-NOSES / 2026-0237
- Conditions
- Colorectal Neoplasms, Incisional Hernia
- Keywords
- Natural Orifice Specimen Extraction, NOSE surgery, Minimally invasive colorectal surgery, Incisional hernia, Laparoscopic colorectal surgery, Transanal specimen extraction, Transvaginal specimen extraction, Patient-reported outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- 30 Mar 2033 (estimated)
- Study completion
- 30 Dec 2033 (estimated)
- First posted
- 29 May 2026 (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.
Natural orifice specimen extraction (NOSE) is a minimally invasive colorectal surgical technique in which the surgical specimen is removed through a natural orifice, including transanal or transvaginal routes, thereby avoiding an abdominal extraction incision. Observational studies suggest that NOSE may reduce wound-related morbidity and improve postoperative recovery, but prospective multicenter data evaluating long-term outcomes remain limited.
AP-NOSES is a prospective, multicenter observational registry evaluating clinical, patient-reported, and long-term wound outcomes following minimally invasive colorectal surgery with NOSE or transabdominal specimen extraction. The primary objective is to compare time to incisional hernia within 24 months between NOSE-eligible patients undergoing planned NOSE extraction and NOSE-eligible patients undergoing planned transabdominal extraction.
Secondary objectives include evaluation of postoperative complications, extraction-related morbidity, bowel function, urinary and sexual function, oncologic outcomes, and long-term patient-reported and clinical outcomes across participating centers.
This study does not alter routine clinical care. Surgical technique, perioperative management, and follow-up are performed according to local institutional practice.
Detailed description
Natural orifice specimen extraction (NOSE) is an established minimally invasive colorectal surgical technique that enables removal of the surgical specimen through transanal or transvaginal routes while avoiding an abdominal specimen extraction incision. Existing retrospective studies and meta-analyses suggest that NOSE may reduce postoperative pain, wound morbidity, and length of hospital stay without compromising oncologic outcomes. However, prospective multicenter data evaluating long-term abdominal wall outcomes and patient-reported outcomes remain limited.
Incisional hernia is a common long-term complication following colorectal surgery and is closely associated with the abdominal extraction site. By avoiding an abdominal extraction incision, NOSE may reduce extraction-site morbidity and long-term incisional hernia risk. AP-NOSES was designed to prospectively evaluate these outcomes in a multicenter setting using predefined eligibility criteria and a concurrent comparator cohort.
AP-NOSES is a prospective observational multicenter registry coordinated by Singapore General Hospital. Consecutive adult patients undergoing elective minimally invasive colorectal resection with planned intact specimen extraction are eligible for enrollment. Participating centers include tertiary colorectal units within the Asia-Pacific region.
The primary comparative analysis is conducted within a predefined NOSE-eligible cohort. Exposure groups are defined according to planned specimen extraction strategy:
- Planned NOSE extraction (transanal or transvaginal), and
- Planned transabdominal extraction among patients meeting protocol NOSE eligibility criteria.
Planned and achieved extraction routes, reasons for non-performance of NOSE, operative details, postoperative complications, and oncologic outcomes are prospectively recorded.
The primary outcome is time to incisional hernia within 24 months following index colorectal surgery.
Secondary outcomes include postoperative complications, extraction-site morbidity, surgical site infection, readmission, reoperation, pathologic outcomes, patient-reported quality-of-life and functional outcomes, bowel function, urinary and sexual function in selected patients, and oncologic outcomes including recurrence and disease-free survival.
Patient-reported outcomes are assessed using validated instruments including EQ-5D-5L, Body Image Scale (BIS), Low Anterior Resection Syndrome (LARS) score, International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), and Female Sexual Function Index-6 (FSFI-6), where applicable.
This study is observational and does not mandate changes to standard surgical or postoperative management. Data are entered into a secure centralized REDCap database using coded study identifiers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Planned NOSE Extraction | – | Procedure: Natural Orifice Specimen ExtractionPatients undergoing planned natural orifice specimen extraction (NOSE), including transanal or transvaginal extraction, during elective minimally invasive colorectal surgery. |
| Planned Transabdominal Extraction | – | Procedure: Transabdominal Specimen ExtractionNOSE-eligible patients undergoing planned transabdominal specimen extraction during elective minimally invasive colorectal surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective minimally invasive colorectal resection with planned intact specimen extraction at participating tertiary colorectal centers in the Asia-Pacific region.
Key inclusion criteria (5 listed)
- Age 21 years or older
- Elective minimally invasive colorectal resection (laparoscopic or robotic intent)
- Planned intact specimen extraction
- Eligible for natural orifice specimen extraction (NOSE) or transabdominal specimen extraction according to study protocol
- Ability to provide informed consent
Key exclusion criteria (11 listed)
- Emergency colorectal surgery
- Planned transanal total mesorectal excision (TaTME)
- Planned ultralow anterior resection with planned anastomosis 3 cm or less from the anal verge
- Planned abdominoperineal resection (APR)
- Planned permanent end stoma without restoration of intestinal continuity
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 |
|---|---|---|
| Natural Orifice Specimen ExtractionSpecimen extraction through a natural orifice, including transanal or transvaginal extraction, during minimally invasive colorectal surgery. | Procedure or surgery | Planned NOSE Extraction |
| Transabdominal Specimen ExtractionSpecimen extraction through an abdominal incision during minimally invasive colorectal surgery. | Procedure or surgery | Planned Transabdominal Extraction |
Primary outcome
Time to Incisional Hernia Within 24 Months
Time frame: 24 months after index surgery
Time from index colorectal surgery to first clinical or radiologic diagnosis of incisional hernia at or adjacent to the specimen extraction site.
10 secondary outcomes
Overall Postoperative Complications
Time frame: 30 days after surgery
Surgical Site Infection
Time frame: 30 days after surgery
Extraction-Site Complications
Time frame: 30 days after surgery
Length of Hospital Stay
Time frame: From date of surgery until hospital discharge, up to 30 days
EQ-5D-5L Score
Time frame: Baseline, 6 months, and 12 months after surgery
Body Image Scale (BIS) Score
Time frame: Baseline, 6 months, and 12 months after surgery
Low Anterior Resection Syndrome (LARS) Score
Time frame: 6 months and 12 months after surgery
Local Recurrence
Time frame: Up to 24 months after surgery
Distant Recurrence
Time frame: Up to 24 months after surgery
Disease-Free Survival
Time frame: Up to 24 months after surgery
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 29 May 2026.
- Background: PubMed 36545836den Hartog FPJ, van Egmond S, Poelman MM, Menon AG, Kleinrensink GJ, Lange JF, Tanis PJ, Deerenberg EB. The incidence of extraction site incisional hernia after minimally invasive colorectal surgery: a systematic review and meta-analysis. Colorectal Dis. 2023 Apr;25(4):586-599. doi: 10.1111/codi.16455. Epub 2023 Jan 5.
- Background: PubMed 32851500Chin YH, Decruz GM, Ng CH, Tan HQM, Lim F, Foo FJ, Tai CH, Chong CS. Colorectal resection via natural orifice specimen extraction versus conventional laparoscopic extraction: a meta-analysis with meta-regression. Tech Coloproctol. 2021 Jan;25(1):35-48. doi: 10.1007/s10151-020-02330-6. Epub 2020 Aug 26.
- Background: PubMed 30792863Guan X, Liu Z, Longo A, Cai JC, Tzu-Liang Chen W, Chen LC, Chun HK, Manuel da Costa Pereira J, Efetov S, Escalante R, He QS, Hu JH, Kayaalp C, Kim SH, Khan JS, Kuo LJ, Nishimura A, Nogueira F, Okuda J, Saklani A, Shafik AA, Shen MY, Son JT, Song JM, Sun DH, Uehara K, Wang GY, Wei Y, Xiong ZG, Yao HL, Yu G, Yu SJ, Zhou HT, Lee SH, Tsarkov PV, Fu CG, Wang XS; International Alliance of NOSES. International consensus on natural orifice specimen extraction surgery (NOSES) for colorectal cancer. Gastroenterol Rep (Oxf). 2019 Feb;7(1):24-31. doi: 10.1093/gastro/goy055. Epub 2019 Jan 23.
- Derived from this study: PubMed 42760090Seow-En I, Wong KY, Koo CH, Khor SN, Fu CWP, Chang M, Tan MNA, Kitaguchi D, Ng ZQ, Shao YC, Shen MY, Chang SC, Chen WT; AP-NOSES Collaborative. Prospective multicentre observational study of natural orifice specimen extraction in minimally invasive colorectal surgery in the Asia-Pacific: protocol for the AP-NOSES registry. BMJ Open. 2026 Sep 18;16(9):e123140. doi: 10.1136/bmjopen-2026-123140.
- Individual participant dataSharing planned: Undecided. Individual participant data sharing plans have not yet been finalized. Future sharing of deidentified data may be considered following establishment of multicenter governance, data-sharing agreements, and publication policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Incisional Hernia, run by Singapore General Hospital at 1 site in Singapore.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 29 May 2026. 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 Singapore. 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?
Contact Isaac Seow-En, MBBS, FRCSEd (+6563213853, isaac.seow.en@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Incisional Hernia Within 24 Months (time frame: 24 months after index 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 NCT07615036, which also lists 4 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 29 May 2026.