Gastric CancerNCT06362070

Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy

A study testing DaVinci® Surgical System, Hugo™ RAS System and Versius® Robotic Surgery System in people with Gastric Cancer and Gastrointestinal Cancer, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The object of this exploratory clinical trial is to evaluate intra and post-operative complications in a population that underwent Robotic Gastrectomy, with multiple platforms: DaVinci; Hugo; Versius. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Gastric Cancer, Gastrointestinal Cancer, Neoplasms
What is being tested?: DaVinci® Surgical System, Hugo™ RAS System and Versius® Robotic Surgery System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteItaly
Study dates: 31 Jan 2024to 31 Jul 2025
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age > 18 and < 80 years
Informed consent provided
Primary stomach tumor
Total or subtotal gastrectomy
Tumour stage: T1-4a, any N, M0
ASA I-III
No BMI limits
Upfront surgery or after neoadjuvant chemotherapy

Who cannot join

Extension to esophagectomy
Tumor of the esophago-gastric junction (Siwert I-III)
Emergency surgery
Metastatic patients (stage IV)
Patients undergoing preoperative radiotherapy
Previous major supramesocolic surgery (excluding cholecystectomy)
Other coexisting malignant neoplasms

Trial locations and contacts

1 site in 1 country.

Simone SG Giacopuzzi, MD, Prof contact

+39 0458127510

simone.giacopuzzi@univr.it

Italy1 site, 1 recruiting

General and Upper GI Unit
Verona, 37126
Simone SG Giacopuzzi, MD, Prof, +39 0458127510, simone.giacopuzzi@univr.it
Simone Giacopuzzi, MD, Prof
Recruiting

Other trials in Italy

About this study

Official title: Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy (COMPAR-G) in Gastric Cancer Patient.

The object of this exploratory clinical trial is to evaluate intra and post-operative complications in a population that underwent Robotic Gastrectomy, with multiple platforms:

DaVinci;
Hugo;
Versius.

This study is divided into two phases: in the first phase, gastrectomy will be performed using both the new platforms (Hugo and Versius) and the standard platform (Da Vinci), to evaluate the feasibility of the surgical procedure. In the second phase, the three platforms will be compared to evaluate any differences in the learning curve for an upper-GI surgeon, expert in laparoscopic surgery but not with robotic one.

The questions it aims to answer are:

Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three different platforms observable?
Are there any differences between the three platforms related to the learning curve for surgeons?

Participants will be enrolled, after obtaining informed consent, in one of the following cohorts:

surgery with the daVinci platform;
surgery with the Hugo platform;
surgery with the Versius platform.

Read the detailed description

Gastrectomy for gastric cancer could be performed through open, laparoscopic and robotic approaches. In the last ten years, robotic surgery, performed with Da Vinci® Robotic System (Intuitive Surgical Inc., Sunnyvale, CA, USA) has been introduced and increasingly used globally also in the field of gastric surgery. Indeed, the technological implementation obtained with the use of robotic surgery should guarantee an easier approach to the different phases of gastric surgery, and in particular to the more complex steps relating to the reconstructive phase of the operation.

Recently, after Intuitive patent expiration, two new CE-marked robotic platforms are available in Europe for minimally invasive procedures:

Versius® Robotic Surgery System, (Cambridge Medical Robotics (CMR) Ltd., Cambridge, UK);
HugoTM RAS (Medtronic Dublin, Ireland; Minneapolis, MN, USA).

Both platforms are currently used for urological and gynecological procedures, but, no experiences are reported in Literature related to the field of oncological esophago-gastric surgery. In order to provide evidence regarding the new robotic platforms, the COMPAR-G study has been designed to directly compare the Da Vinci® (as standard), Versius® and HugoTM RAS robotic platforms during gastrectomy.

In this regard, this study was proposed, divided into two phases: a first phase for feasibility of surgical procedure with different platforms and the second one to evaluate the learning curve for surgeons.

This second phase will be carried out only in the event of an extension of the rental of the two new platforms for a further period of one year.

Conditions: Gastric Cancer, Gastrointestinal Cancer, Neoplasms, Gastric Diffuse Adenocarcinoma, Gastric Neoplasm, Stomach Adenocarcinoma
Being tested: DaVinci® Surgical System, Hugo™ RAS System, Versius® Robotic Surgery System
Keywords: Robotic-assisted surgery, Multiple surgical platforms, Postoperative complications, Operative outcomes, Gastrectomy
Medical subject headings: Stomach Neoplasms, Gastrointestinal Neoplasms, Neoplasms, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DaVinci® Surgical SystemDevice
Assisted-robotic radical Gastrectomy
Hugo™ RAS SystemDevice
Assisted-robotic radical Gastrectomy
Versius® Robotic Surgery SystemDevice
Assisted-robotic radical Gastrectomy

Study groups in NCT06362070
Study group	Role	What they receive
DaVinci® Surgical System	Active comparator	Robot-assisted total or subtotal Gastrectomy is carried out through daVinci platform. (10 patients enrolled for phase 1 of the study and 15 patients for phase 2) Receives: Device: DaVinci® Surgical System
Hugo™ RAS System	Experimental	Robot-assisted total or subtotal Gastrectomy is carried out through Hugo platform. (10 patients enrolled for phase 1 of the study and 15 patients for phase 2) Receives: Device: Hugo™ RAS System
Versius® Robotic Surgery System	Experimental	Robot-assisted total or subtotal Gastrectomy is carried out through Versius platform. (10 patients enrolled for phase 1 of the study and 15 patients for phase 2) Receives: Device: Versius® Robotic Surgery System

What is being measured

The primary outcome is the main question the study is designed to answer.

Conversion rate to open or laparoscopic approach (Phase 1)
Number of procedures in which it is necessary to convert to open or laparoscopic approach, due to surgical and/or oncological needs
Measured: Intraoperative
Number of participants with major intraoperative complications (Phase 1)
Major complications are considered according to the GASTRODATA definition (Unintentional intraoperative damage to major vessels and/or organs requiring reconstruction or resection. Intraoperative bleeding requiring urgent treatment. Unforeseen medical conditions that interrupt or change the planned procedure) and according to Clavien-Dindo Classification (7 grades: I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication.
Measured: Intraoperative
Evaluation of surgical times of the standardized procedures (Phase 2)
Analysis of surgical times (as minutes of the different surgical steps of the standardized procedure).
Measured: Intraoperative
Analysis of video of surgical procedures (Phase 2)
Evaluation of analysis of video of surgical procedure, as deviations from the standard.
Measured: Intraoperative

Secondary outcomes (16)

Estimated Blood Loss
Volume of blood loss (ml)
Measured: Intraoperative
Overall duration of the surgery
Minutes
Measured: Intraoperative
Anesthesia, Lymphadenectomy, Gastrectomy (10 different surgical steps)
Minutes
Measured: Entrance of patient into operating room until completion of surgery
Number of participants with major postoperative complications
Major complications are considered according to GASTRODATA definition (surgical and/or general) and according to Clavien-Dindo Classification (7 grades: I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication
Measured: Until 90 days post surgery
Compliance rate to ERAS protocol
Adherence to Enhanced recovery after surgery for gastric cancer (ERAS-GC) protocol, which involves a rapid mobilisation and refeeding of patiens.
Measured: 1-7 days postoperative
Postoperative hospitalization
Days of recovery until the date of release
Measured: From the surgery day up to 20 days postoperative
Postoperative pain
Numerical Rating Scale (NRS) 0-10 scale for the self-reported rate of pain: zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 1-5 days postoperative
Re-admission rate to hospitalization
Number of patients readmitted to the hospital for postoperative complications
Measured: Up to 90 days postoperative
Damage due to positioning
Number of damage due to positioning on the operating bed, during the surgical procedure
Measured: Intraoperative
Positive Surgical Margin
Positive margin (distal or proximal) at histological examination
Measured: Up to 2 weeks postoperative (during histological analysis)
Lymph nodes resection
Number of lymph nodes removed
Measured: Up to 2 weeks postoperative (during histological analysis)
Quality of Life Evaluation
EORTC QLQ-C30 questionnaire (30-item instrument designed to measure quality of life in all cancer patients) and EORTC STO-22 questionnaire (for measuring the QOL of patient with gastric cancer)
Measured: Postoperaive (follow up at 1 month)
Time taken for platform-related technical steps
Set up of operating table, Electric connections, Draping, Undraping, Docking, Undocking, Cleaning: time in minutes
Measured: From the room setting, through surgical procedure until postoperative room restoration for each of expected surgeries
Possible malfunction of the platform
Note
Measured: Intraoperative
Non-Technical Skills Assessment (NTS) demonstrated by members of the surgical team during the intraoperative phase.
Targeted observation with "I.C.A.R.S" checklist (Interpersonal and Cognitive
Assessment for Robotic Surgery) which includes following domains:
Checklist and equipment; Interpersonal skills and Cognitive skills.
Measured: Intraoperative
Procedure-related costs
Estimate
Measured: From surgical procedure up to 90 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 202431 Jul 2025

First posted12 Apr 2024
Study start31 Jan 2024
Primary completion30 Mar 2024
Study completion31 Jul 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Gastric 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: Parallel groups
Masking: None (open label)
Enrolment: 75 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06362070
Sponsor's protocol ID: COMPAR-G
Status last verified: Apr 2024
First submitted: 3 Apr 2024
Last updated: 12 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Haig F, Medeiros ACB, Chitty K, Slack M. Usability assessment of Versius, a new robot-assisted surgical device for use in minimal access surgery. BMJ Surg Interv Health Technol. 2020 May 22;2(1):e000028. doi: 10.1136/bmjsit-2019-000028. eCollection 2020.
PubMed 35047788
Peters BS, Armijo PR, Krause C, Choudhury SA, Oleynikov D. Review of emerging surgical robotic technology. Surg Endosc. 2018 Apr;32(4):1636-1655. doi: 10.1007/s00464-018-6079-2. Epub 2018 Feb 13.
PubMed 29442240
Solaini L, D'Ignazio A, Marrelli D, Marano L, Avanzolini A, Morgagni P, Roviello F, Ercolani G. The effect of learning curve on perioperative outcomes of robotic gastrectomy in two western high-volume centers. Int J Med Robot. 2021 Apr;17(2):e2212. doi: 10.1002/rcs.2212. Epub 2021 Jan 8.
PubMed 33340239
Li Z, Qian F, Zhao Y, Chen J, Zhang F, Li Z, Wang X, Li P, Liu J, Wen Y, Feng Q, Shi Y, Yu P. A comparative study on perioperative outcomes between robotic versus laparoscopic D2 total gastrectomy. Int J Surg. 2022 Jun;102:106636. doi: 10.1016/j.ijsu.2022.106636. Epub 2022 Apr 26.
PubMed 35472517
Shibasaki S, Suda K, Hisamori S, Obama K, Terashima M, Uyama I. Robotic gastrectomy for gastric cancer: systematic review and future directions. Gastric Cancer. 2023 May;26(3):325-338. doi: 10.1007/s10120-023-01389-y. Epub 2023 Apr 3.
PubMed 37010634
Prata F, Ragusa A, Tempesta C, Iannuzzi A, Tedesco F, Cacciatore L, Raso G, Civitella A, Tuzzolo P, Calle P, Pira M, Pino M, Ricci M, Fantozzi M, Prata SM, Anceschi U, Simone G, Scarpa RM, Papalia R. State of the Art in Robotic Surgery with Hugo RAS System: Feasibility, Safety and Clinical Applications. J Pers Med. 2023 Aug 6;13(8):1233. doi: 10.3390/jpm13081233.
PubMed 37623483
Baiocchi GL, Giacopuzzi S, Marrelli D, Reim D, Piessen G, Matos da Costa P, Reynolds JV, Meyer HJ, Morgagni P, Gockel I, Lara Santos L, Jensen LS, Murphy T, Preston SR, Ter-Ovanesov M, Fumagalli Romario U, Degiuli M, Kielan W, Monig S, Kolodziejczyk P, Polkowski W, Hardwick R, Pera M, Johansson J, Schneider PM, de Steur WO, Gisbertz SS, Hartgrink H, van Sandick JW, Portolani N, Holscher AH, Botticini M, Roviello F, Mariette C, Allum W, De Manzoni G. International consensus on a complications list after gastrectomy for cancer. Gastric Cancer. 2019 Jan;22(1):172-189. doi: 10.1007/s10120-018-0839-5. Epub 2018 May 30.
PubMed 29846827

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy (COMPAR-G) in Gastric Cancer Patient.
ClinicalTrials.gov ID: NCT06362070
Acronym / sponsor ID: COMPAR-G
Conditions: Gastric Cancer, Gastrointestinal Cancer, Neoplasms, Gastric Diffuse Adenocarcinoma, Gastric Neoplasm, Stomach Adenocarcinoma
Keywords: Robotic-assisted surgery, Multiple surgical platforms, Postoperative complications, Operative outcomes, Gastrectomy
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 75 participants (estimated)
Lead sponsor: Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
Study start: 31 Jan 2024 (actual)
Primary completion: 30 Mar 2024 (actual)
Study completion: 31 Jul 2025 (estimated)
First posted: 12 Apr 2024 (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 object of this exploratory clinical trial is to evaluate intra and post-operative complications in a population that underwent Robotic Gastrectomy, with multiple platforms:

DaVinci;
Hugo;
Versius.

The questions it aims to answer are:

Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three different platforms observable?
Are there any differences between the three platforms related to the learning curve for surgeons?

Participants will be enrolled, after obtaining informed consent, in one of the following cohorts:

surgery with the daVinci platform;
surgery with the Hugo platform;
surgery with the Versius platform.

Detailed description

Recently, after Intuitive patent expiration, two new CE-marked robotic platforms are available in Europe for minimally invasive procedures:

Versius® Robotic Surgery System, (Cambridge Medical Robotics (CMR) Ltd., Cambridge, UK);
HugoTM RAS (Medtronic Dublin, Ireland; Minneapolis, MN, USA).

This second phase will be carried out only in the event of an extension of the rental of the two new platforms for a further period of one year.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
DaVinci® Surgical System	Active comparator	Device: DaVinci® Surgical SystemRobot-assisted total or subtotal Gastrectomy is carried out through daVinci platform. (10 patients enrolled for phase 1 of the study and 15 patients for phase 2)
Hugo™ RAS System	Experimental	Device: Hugo™ RAS SystemRobot-assisted total or subtotal Gastrectomy is carried out through Hugo platform. (10 patients enrolled for phase 1 of the study and 15 patients for phase 2)
Versius® Robotic Surgery System	Experimental	Device: Versius® Robotic Surgery SystemRobot-assisted total or subtotal Gastrectomy is carried out through Versius platform. (10 patients enrolled for phase 1 of the study and 15 patients for phase 2)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age > 18 and < 80 years
Informed consent provided
Primary stomach tumor
Total or subtotal gastrectomy
Tumour stage: T1-4a, any N, M0

Key exclusion criteria (7 listed)

Extension to esophagectomy
Tumor of the esophago-gastric junction (Siwert I-III)
Emergency surgery
Metastatic patients (stage IV)
Patients undergoing preoperative radiotherapy

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
DaVinci® Surgical SystemAssisted-robotic radical Gastrectomy	Device	DaVinci® Surgical System
Hugo™ RAS SystemAssisted-robotic radical Gastrectomy	Device	Hugo™ RAS System
Versius® Robotic Surgery SystemAssisted-robotic radical Gastrectomy	Device	Versius® Robotic Surgery System

Primary outcome

Conversion rate to open or laparoscopic approach (Phase 1)
Time frame: Intraoperative
Number of procedures in which it is necessary to convert to open or laparoscopic approach, due to surgical and/or oncological needs
Number of participants with major intraoperative complications (Phase 1)
Time frame: Intraoperative
Major complications are considered according to the GASTRODATA definition (Unintentional intraoperative damage to major vessels and/or organs requiring reconstruction or resection. Intraoperative bleeding requiring urgent treatment. Unforeseen medical conditions that interrupt or change the planned procedure) and according to Clavien-Dindo Classification (7 grades: I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication.
Evaluation of surgical times of the standardized procedures (Phase 2)
Time frame: Intraoperative
Analysis of surgical times (as minutes of the different surgical steps of the standardized procedure).
Analysis of video of surgical procedures (Phase 2)
Time frame: Intraoperative
Evaluation of analysis of video of surgical procedure, as deviations from the standard.

16 secondary outcomes

Estimated Blood Loss
Time frame: Intraoperative
Overall duration of the surgery
Time frame: Intraoperative
Anesthesia, Lymphadenectomy, Gastrectomy (10 different surgical steps)
Time frame: Entrance of patient into operating room until completion of surgery
Number of participants with major postoperative complications
Time frame: Until 90 days post surgery
Compliance rate to ERAS protocol
Time frame: 1-7 days postoperative
Postoperative hospitalization
Time frame: From the surgery day up to 20 days postoperative
Postoperative pain
Time frame: 1-5 days postoperative
Re-admission rate to hospitalization
Time frame: Up to 90 days postoperative
Damage due to positioning
Time frame: Intraoperative
Positive Surgical Margin
Time frame: Up to 2 weeks postoperative (during histological analysis)
Lymph nodes resection
Time frame: Up to 2 weeks postoperative (during histological analysis)
Quality of Life Evaluation
Time frame: Postoperaive (follow up at 1 month)
Time taken for platform-related technical steps
Time frame: From the room setting, through surgical procedure until postoperative room restoration for each of expected surgeries
Possible malfunction of the platform
Time frame: Intraoperative
Non-Technical Skills Assessment (NTS) demonstrated by members of the surgical team during the intraoperative phase.
Time frame: Intraoperative
Procedure-related costs
Time frame: From surgical procedure up to 90 days after surgery

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
Results publication: PubMed 35047788Haig F, Medeiros ACB, Chitty K, Slack M. Usability assessment of Versius, a new robot-assisted surgical device for use in minimal access surgery. BMJ Surg Interv Health Technol. 2020 May 22;2(1):e000028. doi: 10.1136/bmjsit-2019-000028. eCollection 2020.
Results publication: PubMed 29442240Peters BS, Armijo PR, Krause C, Choudhury SA, Oleynikov D. Review of emerging surgical robotic technology. Surg Endosc. 2018 Apr;32(4):1636-1655. doi: 10.1007/s00464-018-6079-2. Epub 2018 Feb 13.
Results publication: PubMed 33340239Solaini L, D'Ignazio A, Marrelli D, Marano L, Avanzolini A, Morgagni P, Roviello F, Ercolani G. The effect of learning curve on perioperative outcomes of robotic gastrectomy in two western high-volume centers. Int J Med Robot. 2021 Apr;17(2):e2212. doi: 10.1002/rcs.2212. Epub 2021 Jan 8.
Results publication: PubMed 35472517Li Z, Qian F, Zhao Y, Chen J, Zhang F, Li Z, Wang X, Li P, Liu J, Wen Y, Feng Q, Shi Y, Yu P. A comparative study on perioperative outcomes between robotic versus laparoscopic D2 total gastrectomy. Int J Surg. 2022 Jun;102:106636. doi: 10.1016/j.ijsu.2022.106636. Epub 2022 Apr 26.
Results publication: PubMed 37010634Shibasaki S, Suda K, Hisamori S, Obama K, Terashima M, Uyama I. Robotic gastrectomy for gastric cancer: systematic review and future directions. Gastric Cancer. 2023 May;26(3):325-338. doi: 10.1007/s10120-023-01389-y. Epub 2023 Apr 3.
Results publication: PubMed 37623483Prata F, Ragusa A, Tempesta C, Iannuzzi A, Tedesco F, Cacciatore L, Raso G, Civitella A, Tuzzolo P, Calle P, Pira M, Pino M, Ricci M, Fantozzi M, Prata SM, Anceschi U, Simone G, Scarpa RM, Papalia R. State of the Art in Robotic Surgery with Hugo RAS System: Feasibility, Safety and Clinical Applications. J Pers Med. 2023 Aug 6;13(8):1233. doi: 10.3390/jpm13081233.
Results publication: PubMed 29846827Baiocchi GL, Giacopuzzi S, Marrelli D, Reim D, Piessen G, Matos da Costa P, Reynolds JV, Meyer HJ, Morgagni P, Gockel I, Lara Santos L, Jensen LS, Murphy T, Preston SR, Ter-Ovanesov M, Fumagalli Romario U, Degiuli M, Kielan W, Monig S, Kolodziejczyk P, Polkowski W, Hardwick R, Pera M, Johansson J, Schneider PM, de Steur WO, Gisbertz SS, Hartgrink H, van Sandick JW, Portolani N, Holscher AH, Botticini M, Roviello F, Mariette C, Allum W, De Manzoni G. International consensus on a complications list after gastrectomy for cancer. Gastric Cancer. 2019 Jan;22(1):172-189. doi: 10.1007/s10120-018-0839-5. Epub 2018 May 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.

Simone SG Giacopuzzi, MD, Prof contact

+39 0458127510

simone.giacopuzzi@univr.it

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Simone SG Giacopuzzi, MD, Prof (+39 0458127510, simone.giacopuzzi@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conversion rate to open or laparoscopic approach (Phase 1) (time frame: Intraoperative). The study lists 4 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 NCT06362070, which also lists 7 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 12 Apr 2024.