Ovarian CancerULTRA-LAPNCT05862740
ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer
A study testing Laparoscopic Debulking Surgery in advanced ovarian cancer and Standard laparotomic Debulking Surgery in advanced ovarian cancer in people with Ovarian Cancer, run by Azienda Ospedaliera di Padova at 1 site in Italy.
Trial summary
ULTRA-LAP is a prospective study is to investigate the safety, efficacy and feasibility of laparoscopic debulking surgery (LDS) for the treatment of patients with advanced ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Laparoscopic Debulking Surgery in advanced ovarian cancer and Standard laparotomic Debulking Surgery in advanced ovarian cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2022to 31 Dec 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced epithelial ovarian cancer (II-IV Stage FIGO) candidates to PDS (primary debulking surgery) or IDS (interval debulking surgery: neoadjuvant chemotherapy followed by IDS).
- Participant is willing and able to give informed consent for participation in the study.
- Female aged 18 years or above.
- Primary diagnosis of advanced epithelial ovarian cancer (tubal and peritoneal cancer included).
Who cannot join
- Comorbidities non-allowing for radical surgery
- Poor Performance Status (Karnofsky Index < 70)
- Concomitant or past history of malignancy, regardless of treatment status
- Recent or past story of pancreatitis or hepatitis
- Recent or past story of pleural effusion or lung injuries or respiratory failure
- Cardiac major pathologies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria di Padova,
Padova, Padova, Veneto, 35128
Matteo Marchetti, MD, matteomarchetti91@gmail.com
Marco Noventa, MD, marco.noventa@gmail.com
About this study
Official title: ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer: a Feasibility Prospective Study
ULTRA-LAP is a prospective study is to investigate the safety, efficacy and feasibility of laparoscopic debulking surgery (LDS) for the treatment of patients with advanced ovarian cancer.
The outcomes to measure are:
Read more
- Safety: the rate of patients experiencing intra- and post-operative early and late morbidities (within the hospitalization and up to 60 days from surgery)
- Efficacy: the rate of patients in which the surgical target set pre-operatively (complete resection) is achieved by laparoscopy.
- Feasibility: the rate of patients who have their procedure completed by laparoscopy
Patients will undergo laparoscopic debulking surgery (LDS) if the surgical target can be met. If it cannot be achieved by laparoscopy the surgeon will convert to laparotomy.
Read the detailed description
The investigators intend to perform a prospective feasibility study on patients with primary diagnosis of advanced ovarian cancer (stage II to IV according to FIGO classification) who are referred to the tertiary cancer centre of the study. The latter is the Department of Gynecology and Obstetrics - Division of Women's and Children's Health - University of Padova - Italy. The statistical sample size calculation identified a minimum of 62 patients. The anticipated enrollment period will be about 4 years.
To confirm the ultimate eligibility to surgery and recruitment in the study, all patients undergo an exploratory laparoscopy (EXL).
The ideal surgical target is complete resection (CR) of all visible disease. Patients who are deemed not amenable to a CR at EXL will start neo-adjuvant chemotherapy. They will be reconsidered for the ULTRA-LAP study at time of interval surgery after 3 cycles of chemotherapy. Criteria for eligibility after neo-adjuvant chemotherapy are the same as per up-front surgery.
All patients recruited in the ULTRA-LAP trial will be discussed at Gynaecologic Oncology Multidisciplinary team (MDT) meeting, where imaging is reviewed and management is agreed. Following MDT decision:
- A Gynaecologic Oncologist will discuss the standard management and the ULTRA-LAP trial at time of out-patient clinic
- The ULTRA-LAP leaflet and consent form will be provided to the patient together with an accurate explanation of the study
- If the patient accepts to enter the study, a study registration form will be filled
- Participation in the study will be confirmed and the forms signed at time of pre-operative assessment and again confirmed at time of in-patient admission ULTRA-LAP trail will include all surgical procedures necessary to accomplish a complete resection (CR) of disease. The most common procedures necessary to obtain a CR are defined by The European Society of Gynaecological Oncology (ESGO), Society of Gynecologic Oncology (SGO) and the The National Institute for Health and Care Excellence (NICE) guidelines. All procedures will be performed by an expert Gynaecologic Oncologist with proven experience and high skills levels in oncological surgery. Once the surgeon realizes that a CR could not be achieved by laparoscopy, but prove to be feasible by laparotomy, the surgery is immediately converted to laparotomy.
Subsequent follow-up:
- During Recovery:
- The patients are going to be monitored daily and any relevant complications will be registered, graded (according to Clavien-Dindo classification) and treated.
- Post recovery:
- 1 st follow-up visit: At time of hospital's discharge an examination will be performed and, if necessary, further exams will be prescribed as appropriate.
- 2 nd follow-up visit: following discharge, the next appointment is in the outpatient clinic roughly 15-20 days from the surgery.
- 3 rd and last visit: at 30 days from the surgery a further appointment will be carried.
At each follow-up appointment the following will be registered:
- Occurrence of complications
- Physical examination
- Changes in normal quality of life.
Achievement of a CR will be determined at time of surgery and confirmed by a pre-chemotherapy CT scan. Should discrepancy arise, CT scan will be reviewed at MDT.
All patients will be closely monitored with a rigorous follow-up program every 90 days for the first two years and then every 120 days for the subsequent 2 years. In addition, all patient could contact the department if any unexpected complications happens between follow-up time.
- Conditions
- Ovarian Cancer
- Being tested
- Laparoscopic Debulking Surgery in advanced ovarian cancer, Standard laparotomic Debulking Surgery in advanced ovarian cancer
- Keywords
- Ovarian cancer, Advanced ovarian cancer, Debulking surgery, Multivisceral surgery, Laparoscopic debulking surgery
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Debulking Surgery in advanced ovarian cancerProcedure or surgery
Laparoscopic debulking will be conducted until the surgical target is achieved or the operation is converted to laparotomy.
Standard laparotomic Debulking Surgery in advanced ovarian cancerProcedure or surgery
Debulking by laparotomy in patients when debulking could not be accomplished by laparoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic debulking surgery - LDS | Experimental | Primary debulking surgery or Interval debulking surgery performed by laparoscopy (P-LDS and I-LDS) Receives: Procedure: Laparoscopic Debulking Surgery in advanced ovarian cancer |
| Debulking surgery - DS | Active comparator | Primary debulking surgery or Interval debulking surgery performed by/converted to laparotomy (PDS and IDS) Receives: Procedure: Standard laparotomic Debulking Surgery in advanced ovarian cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: rate of complications/morbidities
Safety will be measured as the rate of patients experiencing intra- and post-operative early and late morbidities (within and after the hospitalization up to 60 days from surgery) and it will be compared to the morbidity rate of patients having similar surgery by laparotomy. Complications are going to be graded according to Clavien-Dindo classification.
Measured: 60 days
Efficacy: rate of complete resection (CR) in group 1
Efficacy will be measured as the rate of patients in which the surgical target set pre-operatively is achieved by laparoscopy.
Measured: 60 days
Feasibility: rate of procedures completed by laparoscopy
Feasibility will be measured as the rate of patients who have their procedure completed by laparoscopy.
Measured: 60 days
Secondary outcomes (2)
Progression Free Survival (PFS).
the time interval from the surgical treatment to the date of the documented first recurrence of disease, by CA 125 (Carbohydrate Antigen 125) and/or CT scan.
Measured: 5 years
Overall Survival (OS).
time between surgery and death.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start2 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies 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
- Non-randomised
- Intervention model
- Factorial
- Model description
- Group A is the study group (completed laparoscopic debulking); Group B (conversion to laparotomy) is the control group in which laparoscopy could not be completed
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova
- Responsible party
- Principal investigator, Roberto Tozzi, Azienda Ospedaliera di Padova
- Investigators
- Roberto Tozzi, Professor, Principal investigator, Azienda Ospedale Università di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862740
- Sponsor's protocol ID
- 5497/AO/22
- Other IDs
- AOP2674
- Acronym
- ULTRA-LAP
- Status last verified
- May 2023
- First submitted
- 10 Mar 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elattar A, Bryant A, Winter-Roach BA, Hatem M, Naik R. Optimal primary surgical treatment for advanced epithelial ovarian cancer. Cochrane Database Syst Rev. 2011 Aug 10;2011(8):CD007565. doi: 10.1002/14651858.CD007565.pub2.
PubMed 21833960Shih KK, Chi DS. Maximal cytoreductive effort in epithelial ovarian cancer surgery. J Gynecol Oncol. 2010 Jun;21(2):75-80. doi: 10.3802/jgo.2010.21.2.75. Epub 2010 Jun 30.
PubMed 20613895Elstrand MB, Sandstad B, Oksefjell H, Davidson B, Trope CG. Prognostic significance of residual tumor in patients with epithelial ovarian carcinoma stage IV in a 20 year perspective. Acta Obstet Gynecol Scand. 2012 Mar;91(3):308-17. doi: 10.1111/j.1600-0412.2011.01316.x. Epub 2012 Jan 9.
PubMed 22050605Pomel C, Akladios C, Lambaudie E, Rouzier R, Ferron G, Lecuru F, Classe JM, Fourchotte V, Paillocher N, Wattiez A, Montoriol PF, Thivat E, Beguinot M, Canis M. Laparoscopic management of advanced epithelial ovarian cancer after neoadjuvant chemotherapy: a phase II prospective multicenter non-randomized trial (the CILOVE study). Int J Gynecol Cancer. 2021 Dec;31(12):1572-1578. doi: 10.1136/ijgc-2021-002888. Epub 2021 Oct 20.
PubMed 34670829Fagotti A, Gueli Alletti S, Corrado G, Cola E, Vizza E, Vieira M, Andrade CE, Tsunoda A, Favero G, Zapardiel I, Pasciuto T, Scambia G. The INTERNATIONAL MISSION study: minimally invasive surgery in ovarian neoplasms after neoadjuvant chemotherapy. Int J Gynecol Cancer. 2019 Jan;29(1):5-9. doi: 10.1136/ijgc-2018-000012.
PubMed 30640676Tozzi R, Noventa M, Saccardi C, Spagnol G, De Tommasi O, Coldebella D, Marchetti M. Feasibility of laparoscopic Visceral-Peritoneal Debulking (L-VPD) in patients with stage III-IV ovarian cancer: the ULTRA-LAP trial pilot study. J Gynecol Oncol. 2024 Mar;35(2):e14. doi: 10.3802/jgo.2024.35.e14. Epub 2023 Oct 16.
PubMed 37921599
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer: a Feasibility Prospective Study
- ClinicalTrials.gov ID
- NCT05862740
- Acronym / sponsor ID
- ULTRA-LAP / 5497/AO/22
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, Advanced ovarian cancer, Debulking surgery, Multivisceral surgery, Laparoscopic debulking surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Collaborators
- University of Padova
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 May 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.
ULTRA-LAP is a prospective study is to investigate the safety, efficacy and feasibility of laparoscopic debulking surgery (LDS) for the treatment of patients with advanced ovarian cancer.
The outcomes to measure are:
- Safety: the rate of patients experiencing intra- and post-operative early and late morbidities (within the hospitalization and up to 60 days from surgery)
- Efficacy: the rate of patients in which the surgical target set pre-operatively (complete resection) is achieved by laparoscopy.
- Feasibility: the rate of patients who have their procedure completed by laparoscopy
Patients will undergo laparoscopic debulking surgery (LDS) if the surgical target can be met. If it cannot be achieved by laparoscopy the surgeon will convert to laparotomy.
Detailed description
The investigators intend to perform a prospective feasibility study on patients with primary diagnosis of advanced ovarian cancer (stage II to IV according to FIGO classification) who are referred to the tertiary cancer centre of the study. The latter is the Department of Gynecology and Obstetrics - Division of Women's and Children's Health - University of Padova - Italy. The statistical sample size calculation identified a minimum of 62 patients. The anticipated enrollment period will be about 4 years.
To confirm the ultimate eligibility to surgery and recruitment in the study, all patients undergo an exploratory laparoscopy (EXL).
The ideal surgical target is complete resection (CR) of all visible disease. Patients who are deemed not amenable to a CR at EXL will start neo-adjuvant chemotherapy. They will be reconsidered for the ULTRA-LAP study at time of interval surgery after 3 cycles of chemotherapy. Criteria for eligibility after neo-adjuvant chemotherapy are the same as per up-front surgery.
All patients recruited in the ULTRA-LAP trial will be discussed at Gynaecologic Oncology Multidisciplinary team (MDT) meeting, where imaging is reviewed and management is agreed. Following MDT decision:
- A Gynaecologic Oncologist will discuss the standard management and the ULTRA-LAP trial at time of out-patient clinic
- The ULTRA-LAP leaflet and consent form will be provided to the patient together with an accurate explanation of the study
- If the patient accepts to enter the study, a study registration form will be filled
- Participation in the study will be confirmed and the forms signed at time of pre-operative assessment and again confirmed at time of in-patient admission ULTRA-LAP trail will include all surgical procedures necessary to accomplish a complete resection (CR) of disease. The most common procedures necessary to obtain a CR are defined by The European Society of Gynaecological Oncology (ESGO), Society of Gynecologic Oncology (SGO) and the The National Institute for Health and Care Excellence (NICE) guidelines. All procedures will be performed by an expert Gynaecologic Oncologist with proven experience and high skills levels in oncological surgery. Once the surgeon realizes that a CR could not be achieved by laparoscopy, but prove to be feasible by laparotomy, the surgery is immediately converted to laparotomy.
Subsequent follow-up:
- During Recovery:
- The patients are going to be monitored daily and any relevant complications will be registered, graded (according to Clavien-Dindo classification) and treated.
- Post recovery:
- 1 st follow-up visit: At time of hospital's discharge an examination will be performed and, if necessary, further exams will be prescribed as appropriate.
- 2 nd follow-up visit: following discharge, the next appointment is in the outpatient clinic roughly 15-20 days from the surgery.
- 3 rd and last visit: at 30 days from the surgery a further appointment will be carried.
At each follow-up appointment the following will be registered:
- Occurrence of complications
- Physical examination
- Changes in normal quality of life.
Achievement of a CR will be determined at time of surgery and confirmed by a pre-chemotherapy CT scan. Should discrepancy arise, CT scan will be reviewed at MDT.
All patients will be closely monitored with a rigorous follow-up program every 90 days for the first two years and then every 120 days for the subsequent 2 years. In addition, all patient could contact the department if any unexpected complications happens between follow-up time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A is the study group (completed laparoscopic debulking); Group B (conversion to laparotomy) is the control group in which laparoscopy could not be completed
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic debulking surgery - LDS | Experimental | Procedure: Laparoscopic Debulking Surgery in advanced ovarian cancerPrimary debulking surgery or Interval debulking surgery performed by laparoscopy (P-LDS and I-LDS) |
| Debulking surgery - DS | Active comparator | Procedure: Standard laparotomic Debulking Surgery in advanced ovarian cancerPrimary debulking surgery or Interval debulking surgery performed by/converted to laparotomy (PDS and IDS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with advanced epithelial ovarian cancer (II-IV Stage FIGO) candidates to PDS (primary debulking surgery) or IDS (interval debulking surgery: neoadjuvant chemotherapy followed by IDS).
- Participant is willing and able to give informed consent for participation in the study.
- Female aged 18 years or above.
- Primary diagnosis of advanced epithelial ovarian cancer (tubal and peritoneal cancer included).
Key exclusion criteria (6 listed)
- Comorbidities non-allowing for radical surgery
- Poor Performance Status (Karnofsky Index < 70)
- Concomitant or past history of malignancy, regardless of treatment status
- Recent or past story of pancreatitis or hepatitis
- Recent or past story of pleural effusion or lung injuries or respiratory failure
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 Debulking Surgery in advanced ovarian cancerLaparoscopic debulking will be conducted until the surgical target is achieved or the operation is converted to laparotomy. | Procedure or surgery | Laparoscopic debulking surgery - LDS |
| Standard laparotomic Debulking Surgery in advanced ovarian cancerDebulking by laparotomy in patients when debulking could not be accomplished by laparoscopy. | Procedure or surgery | Debulking surgery - DS |
Primary outcome
Safety: rate of complications/morbidities
Time frame: 60 days
Safety will be measured as the rate of patients experiencing intra- and post-operative early and late morbidities (within and after the hospitalization up to 60 days from surgery) and it will be compared to the morbidity rate of patients having similar surgery by laparotomy. Complications are going to be graded according to Clavien-Dindo classification.
Efficacy: rate of complete resection (CR) in group 1
Time frame: 60 days
Efficacy will be measured as the rate of patients in which the surgical target set pre-operatively is achieved by laparoscopy.
Feasibility: rate of procedures completed by laparoscopy
Time frame: 60 days
Feasibility will be measured as the rate of patients who have their procedure completed by laparoscopy.
2 secondary outcomes
Progression Free Survival (PFS).
Time frame: 5 years
Overall Survival (OS).
Time frame: 5 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 May 2023.
- Results publication: PubMed 21833960Elattar A, Bryant A, Winter-Roach BA, Hatem M, Naik R. Optimal primary surgical treatment for advanced epithelial ovarian cancer. Cochrane Database Syst Rev. 2011 Aug 10;2011(8):CD007565. doi: 10.1002/14651858.CD007565.pub2.
- Results publication: PubMed 20613895Shih KK, Chi DS. Maximal cytoreductive effort in epithelial ovarian cancer surgery. J Gynecol Oncol. 2010 Jun;21(2):75-80. doi: 10.3802/jgo.2010.21.2.75. Epub 2010 Jun 30.
- Results publication: PubMed 22050605Elstrand MB, Sandstad B, Oksefjell H, Davidson B, Trope CG. Prognostic significance of residual tumor in patients with epithelial ovarian carcinoma stage IV in a 20 year perspective. Acta Obstet Gynecol Scand. 2012 Mar;91(3):308-17. doi: 10.1111/j.1600-0412.2011.01316.x. Epub 2012 Jan 9.
- Results publication: PubMed 34670829Pomel C, Akladios C, Lambaudie E, Rouzier R, Ferron G, Lecuru F, Classe JM, Fourchotte V, Paillocher N, Wattiez A, Montoriol PF, Thivat E, Beguinot M, Canis M. Laparoscopic management of advanced epithelial ovarian cancer after neoadjuvant chemotherapy: a phase II prospective multicenter non-randomized trial (the CILOVE study). Int J Gynecol Cancer. 2021 Dec;31(12):1572-1578. doi: 10.1136/ijgc-2021-002888. Epub 2021 Oct 20.
- Results publication: PubMed 30640676Fagotti A, Gueli Alletti S, Corrado G, Cola E, Vizza E, Vieira M, Andrade CE, Tsunoda A, Favero G, Zapardiel I, Pasciuto T, Scambia G. The INTERNATIONAL MISSION study: minimally invasive surgery in ovarian neoplasms after neoadjuvant chemotherapy. Int J Gynecol Cancer. 2019 Jan;29(1):5-9. doi: 10.1136/ijgc-2018-000012.
- Derived from this study: PubMed 37921599Tozzi R, Noventa M, Saccardi C, Spagnol G, De Tommasi O, Coldebella D, Marchetti M. Feasibility of laparoscopic Visceral-Peritoneal Debulking (L-VPD) in patients with stage III-IV ovarian cancer: the ULTRA-LAP trial pilot study. J Gynecol Oncol. 2024 Mar;35(2):e14. doi: 10.3802/jgo.2024.35.e14. Epub 2023 Oct 16.
- 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.
Roberto Tozzi, Professor principal investigator
Azienda Ospedale Università di Padova
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 Debulking Surgery in advanced ovarian cancer and Standard laparotomic Debulking Surgery in advanced ovarian cancer in people with Ovarian Cancer, run by Azienda Ospedaliera di Padova at 1 site in Italy.
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 4 inclusion and 6 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 17 May 2023. 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 Italy. 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 Matteo Marchetti, Doctor (0039-049-8213445, matteomarchetti91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: rate of complications/morbidities (time frame: 60 days). The study lists 3 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 NCT05862740, which also lists 6 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 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.