Abdominal Aortic AneurysmNCT07431047
Fast-Track Protocol for Endovascular Aneurysm Repair (EVAR) of Infrarenal Abdominal Aortic Aneurysms
An observational study of Abdominal Aortic Aneurysm and Infrarenal Abdominal Aortic Aneurysm, run by University of Bologna.
Trial summary
The study aims to evaluate the clinical and economic efficacy of a "Fast-Track" protocol for the elective endovascular treatment (EVAR) of infrarenal abdominal aortic aneurysms (AAA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Infrarenal Abdominal Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2026to 31 Dec 2027
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients diagnosed with infrarenal Abdominal Aortic Aneurysm (AAA) or Penetrating Aortic Ulcer (PAU) referred to the Vascular Surgery Unit of Policlinico Sant'Orsola (a tertiary academic medical center). Participants are selected from the standard waiting list for elective repair based on anatomical suitability for a percutaneous approach (Green/Yellow patterns) and social eligibility for the fast-track early discharge protocol.
Who may be able to join
- Patient diagnosed with infrarenal Abdominal Aortic Aneurysm (AAA) indicated for elective endovascular repair.
- Patient diagnosed with Penetrating Aortic Ulcer (PAU) indicated for elective endovascular repair.
- Patient resident in the Bologna metropolitan area OR able to remain within the area for at least 7 days post-procedure.
- Patient with a cohabitant or caregiver available (cannot live alone) to ensure safety during the early post-discharge phase.
- Signed informed consent specifically for local/locoregional anesthesia, the procedure and the specific fast-track pathway.
- Common femoral arteries diameter > 7 mm
Show all 10Show fewer
- Common femoral arteries free of severe calcification (< 50% of vessel circumference), suitable for percutaneous closure device
- Proximal aortic neck length > 15 mm
- Proximal aortic neck diameter < 30 mm
- Proximal aortic neck without severe angulation (<60°) or circumferential thrombus <50%
Who cannot join
- Patient resident outside the Bologna metropolitan area or unable to remain within the area for at least 7 days post-procedure.
- Patient without a cohabitant or caregiver available
- Common femoral arteries diameter <7 mm
- Common femoral arteries with severe calcification (> 50% of vessel circumference), unsuitable for percutaneous closure device
- Proximal aortic neck length < 15 mm
- Proximal aortic neck diameter > 30 mm
Show all 13Show fewer
- Proximal aortic neck with severe angulation (>60°) or circumferential thrombus >50%
- General anesthesia
- Open conversion
- Medical contraindication to local/locoregional anesthesia or patient refusal/inability to cooperate during the procedure.
- Severe Chronic Kidney Disease (glomerular filtration rate > 30 ml/min) requiring exclusively CO2 angiography
- Ruptured or symptomatic aneurysms requiring emergency repair.
- Clinical condition requiring intensive invasive monitoring (e.g., CVC, urinary catheter) prior to the procedure.
About this study
Official title: Fast-Track Protocol for Infrarenal EVAR
The study aims to evaluate the clinical and economic efficacy of a "Fast-Track" protocol for the elective endovascular treatment (EVAR) of infrarenal abdominal aortic aneurysms (AAA). The protocol minimizes invasiveness through the use of local/locoregional anesthesia, a total percutaneous approach, and the avoidance of routine Intensive Care Unit (ICU) admission. The primary goal is to reduce hospital Length of Stay (LOS) to <48 hours and decrease procedural costs, while maintaining safety and increasing patient turnover compared to the standard of care.
Read the detailed description
Endovascular Aneurysm Repair (EVAR) is the guideline-recommended treatment for AAA. Despite its minimally invasive nature, standard pathways often involve general anesthesia (80% of historical cases at the institution) and ICU monitoring. The Vascular Surgery Unit at Policlinico Sant'Orsola proposes a structured Fast-Track protocol involving:
- Strict Patient Selection: Based on anatomical suitability ("Green/Yellow" criteria) and social support availability.
- Peri-operative Management: Same-day admission, procedure performed in a Hybrid Operating Room under local/locoregional anesthesia with percutaneous access. Minimization of invasive monitoring (no central venous catheter, no urinary catheter).
- Post-operative Care: Early mobilization, oral intake on Day 0, and planned discharge on Post-Operative Day (POD) 1 or 2.
- Follow-up: Telemedicine assessment on POD 3, outpatient visit on POD 6, and CT Angiography at 30 days. The study compares outcomes against historical data (Year 2025) to assess reductions in ICU usage, complications, and costs.
- Conditions
- Abdominal Aortic Aneurysm, Infrarenal Abdominal Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs), Iliac Aneurysm
- Keywords
- EVAR, Fast-track Surgery, Local Anesthesia, Percutaneous Access, Cost-Benefit Analysis
- Medical subject headings
- Aortic Aneurysm, Abdominal, Penetrating Atherosclerotic Ulcer, Iliac Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fast-Track EVAR Cohort | Patients with infrarenal Abdominal Aortic Aneurysm (AAA) undergoing elective Endovascular Aneurysm Repair (EVAR) under local or locoregional anesthesia, managed with the multidisciplinary Fast-Track protocol (percutaneous access, early mobilization, and planned discharge within 24-48 hours). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
Technical success is defined as a single composite endpoint. A participant is considered to have achieved technical success only if all of the following criteria are met: successful deployment of the endograft with exclusion of the aneurysm, absence of type I/III endoleaks, patent access vessels, and no conversion to open surgery.. Unit of Measure: Percentage of participants
Measured: Intra-operative
30-Day Aorta-Related Mortality
This outcome is reported as a single overall percentage. Aorta-related mortality is defined as death resulting from any of the following causes: directly attributable to the aortic pathology (e.g., rupture, progression of disease) OR complications related to the procedure/device. A participant experiencing death from any of these specific causes is counted only once towards this single aggregate percentage. Unit of Measure: Percentage of participants
Measured: 30 days
Secondary outcomes (4)
Mean Length of Stay (LOS)
The duration of the hospital stay, calculated from the date of admission for the procedure to the date of hospital discharge.
Measured: From hospital admission to discharge, assessed up to 30 days. Unit of Measure: Days
ICU Admission Rate
The overall rate of admission to the Intensive Care Unit (ICU). This includes both planned and unplanned admissions. It will be reported as a single overall percentage of participants who required an ICU stay. Unit of Measure: Percentage of participants
Measured: Time Frame: Intra-operative up to Post-Operative Day 1
30-Day Mortality and Morbidity
This is defined as a single composite endpoint. It will be reported as the overall percentage of participants who experience at least one of the following events: all-cause mortality OR major adverse events (specifically: re-intervention, conversion to open surgery, or access site complications). A participant experiencing more than one of these events is counted only once towards this single aggregate percentage. Unit of Measure: Percentage of participants
Measured: 30 days
Patient Turnover Rate
Description: The percentage increase in the total annual volume of Endovascular Aneurysm Repair (EVAR) cases treated at the study site(s) during the 1-year study period, calculated relative to the baseline year of 2025. This outcome is evaluated at the institutional level and will be reported as a single overall percentage. Unit of Measure: Percentage
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start11 Feb 2026 (estimated)
- 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 Abdominal Aortic AneurysmStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Gallitto, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431047
- Sponsor's protocol ID
- EVAR-FT-BO2026
- Status last verified
- Jan 2026
- First submitted
- 11 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.
PubMed 29268916Faggioli G, Scalone L, Mantovani LG, Borghetti F, Stella A; PREFER study group. Preferences of patients, their family caregivers and vascular surgeons in the choice of abdominal aortic aneurysms treatment options: the PREFER study. Eur J Vasc Endovasc Surg. 2011 Jul;42(1):26-34. doi: 10.1016/j.ejvs.2010.12.025. Epub 2011 Feb 19.
PubMed 21334928Antoniou GA, Antoniou SA, Torella F. Editor's Choice - Endovascular vs. Open Repair for Abdominal Aortic Aneurysm: Systematic Review and Meta-analysis of Updated Peri-operative and Long Term Data of Randomised Controlled Trials. Eur J Vasc Endovasc Surg. 2020 Mar;59(3):385-397. doi: 10.1016/j.ejvs.2019.11.030. Epub 2019 Dec 30.
PubMed 31899100Isselbacher EM, Preventza O, Hamilton Black J 3rd, Augoustides JG, Beck AW, Bolen MA, Braverman AC, Bray BE, Brown-Zimmerman MM, Chen EP, Collins TJ, DeAnda A Jr, Fanola CL, Girardi LN, Hicks CW, Hui DS, Schuyler Jones W, Kalahasti V, Kim KM, Milewicz DM, Oderich GS, Ogbechie L, Promes SB, Gyang Ross E, Schermerhorn ML, Singleton Times S, Tseng EE, Wang GJ, Woo YJ; Peer Review Committee Members. 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2022 Dec 13;146(24):e334-e482. doi: 10.1161/CIR.0000000000001106. Epub 2022 Nov 2.
PubMed 36322642Wanhainen A, Van Herzeele I, Bastos Goncalves F, Bellmunt Montoya S, Berard X, Boyle JR, D'Oria M, Prendes CF, Karkos CD, Kazimierczak A, Koelemay MJW, Kolbel T, Mani K, Melissano G, Powell JT, Trimarchi S, Tsilimparis N; ESVS Guidelines Committee; Antoniou GA, Bjorck M, Coscas R, Dias NV, Kolh P, Lepidi S, Mees BME, Resch TA, Ricco JB, Tulamo R, Twine CP; Document Reviewers; Branzan D, Cheng SWK, Dalman RL, Dick F, Golledge J, Haulon S, van Herwaarden JA, Ilic NS, Jawien A, Mastracci TM, Oderich GS, Verzini F, Yeung KK. Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2024 Feb;67(2):192-331. doi: 10.1016/j.ejvs.2023.11.002. Epub 2024 Jan 23.
PubMed 38307694Pratesi C, Esposito D, Apostolou D, Attisani L, Bellosta R, Benedetto F, Blangetti I, Bonardelli S, Casini A, Fargion AT, Favaretto E, Freyrie A, Frola E, Miele V, Niola R, Novali C, Panzera C, Pegorer M, Perini P, Piffaretti G, Pini R, Robaldo A, Sartori M, Stigliano A, Taurino M, Veroux P, Verzini F, Zaninelli E, Orso M; Italian Guidelines for Vascular Surgery Collaborators - AAA Group. Guidelines on the management of abdominal aortic aneurysms: updates from the Italian Society of Vascular and Endovascular Surgery (SICVE). J Cardiovasc Surg (Torino). 2022 Jun;63(3):328-352. doi: 10.23736/S0021-9509.22.12330-X.
PubMed 35658387
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast-Track Protocol for Infrarenal EVAR
- ClinicalTrials.gov ID
- NCT07431047
- Acronym / sponsor ID
- EVAR-FT-BO2026
- Conditions
- Abdominal Aortic Aneurysm, Infrarenal Abdominal Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs), Iliac Aneurysm
- Keywords
- EVAR, Fast-track Surgery, Local Anesthesia, Percutaneous Access, Cost-Benefit Analysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 11 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Feb 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.
The study aims to evaluate the clinical and economic efficacy of a "Fast-Track" protocol for the elective endovascular treatment (EVAR) of infrarenal abdominal aortic aneurysms (AAA). The protocol minimizes invasiveness through the use of local/locoregional anesthesia, a total percutaneous approach, and the avoidance of routine Intensive Care Unit (ICU) admission. The primary goal is to reduce hospital Length of Stay (LOS) to <48 hours and decrease procedural costs, while maintaining safety and increasing patient turnover compared to the standard of care.
Detailed description
Endovascular Aneurysm Repair (EVAR) is the guideline-recommended treatment for AAA. Despite its minimally invasive nature, standard pathways often involve general anesthesia (80% of historical cases at the institution) and ICU monitoring. The Vascular Surgery Unit at Policlinico Sant'Orsola proposes a structured Fast-Track protocol involving:
- Strict Patient Selection: Based on anatomical suitability ("Green/Yellow" criteria) and social support availability.
- Peri-operative Management: Same-day admission, procedure performed in a Hybrid Operating Room under local/locoregional anesthesia with percutaneous access. Minimization of invasive monitoring (no central venous catheter, no urinary catheter).
- Post-operative Care: Early mobilization, oral intake on Day 0, and planned discharge on Post-Operative Day (POD) 1 or 2.
- Follow-up: Telemedicine assessment on POD 3, outpatient visit on POD 6, and CT Angiography at 30 days. The study compares outcomes against historical data (Year 2025) to assess reductions in ICU usage, complications, and costs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fast-Track EVAR Cohort | – | –Patients with infrarenal Abdominal Aortic Aneurysm (AAA) undergoing elective Endovascular Aneurysm Repair (EVAR) under local or locoregional anesthesia, managed with the multidisciplinary Fast-Track protocol (percutaneous access, early mobilization, and planned discharge within 24-48 hours). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients diagnosed with infrarenal Abdominal Aortic Aneurysm (AAA) or Penetrating Aortic Ulcer (PAU) referred to the Vascular Surgery Unit of Policlinico Sant'Orsola (a tertiary academic medical center). Participants are selected from the standard waiting list for elective repair based on anatomical suitability for a percutaneous approach (Green/Yellow patterns) and social eligibility for the fast-track early discharge protocol.
Key inclusion criteria (10 listed)
- Patient diagnosed with infrarenal Abdominal Aortic Aneurysm (AAA) indicated for elective endovascular repair.
- Patient diagnosed with Penetrating Aortic Ulcer (PAU) indicated for elective endovascular repair.
- Patient resident in the Bologna metropolitan area OR able to remain within the area for at least 7 days post-procedure.
- Patient with a cohabitant or caregiver available (cannot live alone) to ensure safety during the early post-discharge phase.
- Signed informed consent specifically for local/locoregional anesthesia, the procedure and the specific fast-track pathway.
Key exclusion criteria (13 listed)
- Patient resident outside the Bologna metropolitan area or unable to remain within the area for at least 7 days post-procedure.
- Patient without a cohabitant or caregiver available
- Common femoral arteries diameter <7 mm
- Common femoral arteries with severe calcification (> 50% of vessel circumference), unsuitable for percutaneous closure device
- Proximal aortic neck length < 15 mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical Success
Time frame: Intra-operative
Technical success is defined as a single composite endpoint. A participant is considered to have achieved technical success only if all of the following criteria are met: successful deployment of the endograft with exclusion of the aneurysm, absence of type I/III endoleaks, patent access vessels, and no conversion to open surgery.. Unit of Measure: Percentage of participants
30-Day Aorta-Related Mortality
Time frame: 30 days
This outcome is reported as a single overall percentage. Aorta-related mortality is defined as death resulting from any of the following causes: directly attributable to the aortic pathology (e.g., rupture, progression of disease) OR complications related to the procedure/device. A participant experiencing death from any of these specific causes is counted only once towards this single aggregate percentage. Unit of Measure: Percentage of participants
4 secondary outcomes
Mean Length of Stay (LOS)
Time frame: From hospital admission to discharge, assessed up to 30 days. Unit of Measure: Days
ICU Admission Rate
Time frame: Time Frame: Intra-operative up to Post-Operative Day 1
30-Day Mortality and Morbidity
Time frame: 30 days
Patient Turnover Rate
Time frame: 1 year
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 24 Feb 2026.
- Background: PubMed 29268916Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.
- Background: PubMed 21334928Faggioli G, Scalone L, Mantovani LG, Borghetti F, Stella A; PREFER study group. Preferences of patients, their family caregivers and vascular surgeons in the choice of abdominal aortic aneurysms treatment options: the PREFER study. Eur J Vasc Endovasc Surg. 2011 Jul;42(1):26-34. doi: 10.1016/j.ejvs.2010.12.025. Epub 2011 Feb 19.
- Background: PubMed 31899100Antoniou GA, Antoniou SA, Torella F. Editor's Choice - Endovascular vs. Open Repair for Abdominal Aortic Aneurysm: Systematic Review and Meta-analysis of Updated Peri-operative and Long Term Data of Randomised Controlled Trials. Eur J Vasc Endovasc Surg. 2020 Mar;59(3):385-397. doi: 10.1016/j.ejvs.2019.11.030. Epub 2019 Dec 30.
- Background: PubMed 36322642Isselbacher EM, Preventza O, Hamilton Black J 3rd, Augoustides JG, Beck AW, Bolen MA, Braverman AC, Bray BE, Brown-Zimmerman MM, Chen EP, Collins TJ, DeAnda A Jr, Fanola CL, Girardi LN, Hicks CW, Hui DS, Schuyler Jones W, Kalahasti V, Kim KM, Milewicz DM, Oderich GS, Ogbechie L, Promes SB, Gyang Ross E, Schermerhorn ML, Singleton Times S, Tseng EE, Wang GJ, Woo YJ; Peer Review Committee Members. 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2022 Dec 13;146(24):e334-e482. doi: 10.1161/CIR.0000000000001106. Epub 2022 Nov 2.
- Background: PubMed 38307694Wanhainen A, Van Herzeele I, Bastos Goncalves F, Bellmunt Montoya S, Berard X, Boyle JR, D'Oria M, Prendes CF, Karkos CD, Kazimierczak A, Koelemay MJW, Kolbel T, Mani K, Melissano G, Powell JT, Trimarchi S, Tsilimparis N; ESVS Guidelines Committee; Antoniou GA, Bjorck M, Coscas R, Dias NV, Kolh P, Lepidi S, Mees BME, Resch TA, Ricco JB, Tulamo R, Twine CP; Document Reviewers; Branzan D, Cheng SWK, Dalman RL, Dick F, Golledge J, Haulon S, van Herwaarden JA, Ilic NS, Jawien A, Mastracci TM, Oderich GS, Verzini F, Yeung KK. Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2024 Feb;67(2):192-331. doi: 10.1016/j.ejvs.2023.11.002. Epub 2024 Jan 23.
- Background: PubMed 35658387Pratesi C, Esposito D, Apostolou D, Attisani L, Bellosta R, Benedetto F, Blangetti I, Bonardelli S, Casini A, Fargion AT, Favaretto E, Freyrie A, Frola E, Miele V, Niola R, Novali C, Panzera C, Pegorer M, Perini P, Piffaretti G, Pini R, Robaldo A, Sartori M, Stigliano A, Taurino M, Veroux P, Verzini F, Zaninelli E, Orso M; Italian Guidelines for Vascular Surgery Collaborators - AAA Group. Guidelines on the management of abdominal aortic aneurysms: updates from the Italian Society of Vascular and Endovascular Surgery (SICVE). J Cardiovasc Surg (Torino). 2022 Jun;63(3):328-352. doi: 10.23736/S0021-9509.22.12330-X.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and Infrarenal Abdominal Aortic Aneurysm, run by University of Bologna.
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 10 inclusion and 13 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: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: Intra-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07431047, 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 24 Feb 2026.