Soft Tissue SurgeriesMARSNCT06974955
A Study on the Safety and Effectiveness of the Mantra™ Surgical Robotic System for Soft Tissue Surgeries
An observational study of Soft Tissue Surgeries, run by Sudhir Srivastava Innovations Pvt. Ltd. at 1 site in India.
Trial summary
A Real-World, multicentre retrospective study to evaluate the clinical performance and safety of MantraTM Surgical Robotic System for soft tissue surgeries. The purpose of this retrospective study is to evaluate the clinical performance and safety of the Mantra™ Surgical Robotic System, Model 3.0, for soft tissue… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Soft Tissue Surgeries
- How many people
- 365 participants
- Where
- 1 siteIndia
- Study dates
- May 2025to Nov 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include patients who have undergone soft tissue surgeries using the Mantra™ Surgical Robotic System (3.0)
Who may be able to join
- Participants must meet all of the following criteria to be eligible for inclusion in this retrospective clinical study of the SSI Mantra 3.0 Surgical Robotic System.
- Patients who have previously undergone surgery using the Mantra™ Surgical Robotic System (Model 3.0) for the following procedures mentioned in Appendix D
Who cannot join
- Patients with missing data on primary endpoints.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Real-World, Multicenter, Retrospective Study to Evaluate the Clinical Performance and Safety of MantraTM Surgical Robotic System for Soft Tissue Surgeries
A Real-World, multicentre retrospective study to evaluate the clinical performance and safety of MantraTM Surgical Robotic System for soft tissue surgeries.
The purpose of this retrospective study is to evaluate the clinical performance and safety of the Mantra™ Surgical Robotic System, Model 3.0, for soft tissue surgeries. It aims to provide real-world evidence on the system's reliability, safety, and effectiveness in the real world population. The SSI Mantra 3.0 Surgical Robotic System is an advanced, modular, and cost-effective robotic-assisted surgical platform designed to enhance precision, flexibility, and control in minimally invasive surgeries (MIS).
The objective of this retrospective study is to assess the clinical performance and safety of the Mantra™ Surgical Robotic System in performing various soft tissue surgeries based on retrospective data analysis.
Read the detailed description
A Real-World, multicentre retrospective study to evaluate the clinical performance and safety of MantraTM Surgical Robotic System for soft tissue surgeries.
Objective : To assess the clinical performance and safety of the Mantra™ Surgical Robotic System in performing various soft tissue surgeries based on retrospective data analysis.
Study Outcomes: The retrospective analysis of the Mantra Surgical Robotic System focused on evaluating its clinical performance, safety and efficacy in minimally invasive surgeries. The study outcomes were assessed based on surgical safety and efficacy parameters, intraoperative efficiency, post-operative recovery, and system utilization trends.
Primary Study Outcomes
- Primary Effectiveness Endpoint
- Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP).
- Successful completion of the procedure using the SSI Mantra 3.0 Surgical Robotic System as planned.
- Primary Safety Endpoint
- Rate of Total Intraoperative and Postoperative Serious Adverse Events (SAE) up to 30 days post-procedure.
- Assessment of device-related complications . Secondary Study Outcomes
- Operative Time
- Measured from skin incision to skin closure to assess efficiency. 2. Estimated Blood Loss (Intraoperative)
- Quantification of blood loss during surgery. 3. Need for Blood Transfusion
- Evaluation of cases requiring intraoperative blood transfusion. 4. Intraoperative Complications
- Identification and classification of adverse events occurring during surgery. 5. Return to Operating Room within 24 Hours
- Evaluation of unplanned reoperations. 6. Length of Hospital Stay
- Time from hospital admission to discharge post-surgery. 7. Readmission to Hospital within 30 Days
- Tracking of unexpected hospital readmissions. 8. Reoperation within 30 Days
- Incidence of repeat surgical interventions. 9. Mortality Rate at 30 Days
- Evaluation of patient survival post-procedure. 10. Device Deficiencies and Use Errors
- Documentation of device-related malfunctions or improper usage. 11. All Adverse Events
- Comprehensive assessment of both minor and major adverse effects. 12. Device Performance Data
- Monitoring of unplanned instrument usage, system clashes, collision detection, and alarm activations.
Timepoints: Day of surgery - 30 days (follow-up). Study Design: This is a retrospective, multicentre study designed to collect and analyze data from surgeries performed using the Mantra™ Surgical Robotic System, Models 3.0,. The study will evaluate clinical performance, safety, and patient outcomes across approximately twenty centers with a target sample size of 365 patients.
- Conditions
- Soft Tissue Surgeries
- Keywords
- Retrospective Study, Real World, Mantra TM Surgical Robotic System, soft tissue surgeries
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 |
|---|---|---|
| Patients who have previously undergone surgery using the Mantra™ Surgical Robotic System 3.0 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP)
- Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP).
Measured: 1 day
Successful completion of procedures without the need for conversion
Successful completion of procedures without the need for conversion
Measured: 1 day
Rate of intraoperative and postoperative serious adverse events (SAEs) occurring up to 30 days post-procedure
Rate of intraoperative and postoperative serious adverse events (SAEs) occurring up to 30 days post-procedure
Measured: 30 days
Evaluation of surgical complications, including infections, haemorrhage, and device-related adverse events
Evaluation of surgical complications, including infections, haemorrhage, and device-related adverse events
Measured: 30 day
Secondary outcomes (12)
Operative Time - Measured from skin incision to skin closure to assess efficiency
Measured from skin incision to skin closure to assess efficiency
Measured: 1 day
Estimated Blood Loss (Intraoperative) - Quantification of Blood loss during surgery
Quantification of blood loss during surgery
Measured: 1 day
Need for Blood Transfusion - Evaluation of cases requiring intraoperative blood transfusion
Evaluation of cases requiring intraoperative blood transfusion
Measured: 1 day
Intraoperative Complications - Identification and classification of adverse events occurring during surgery
Identification and classification of adverse events occurring during surgery
Measured: 1 day
Return to Operating Room within 24 Hours - Evaluation of unplanned reoperations
Evaluation of unplanned reoperations
Measured: 1 day
Length of Hospital Stay - Time from hospital admission to discharge post-surgery
Time from hospital admission to discharge post-surgery
Measured: 30 days
Readmission to Hospital within 30 Days - Tracking of unexpected hospital readmissions
Tracking of unexpected hospital readmissions
Measured: 30 days
Reoperation within 30 Days - Incidence of repeat surgical interventions
Incidence of repeat surgical interventions
Measured: 30 days
Mortality Rate at 30 Days - Evaluation of patient survival post-procedure
Evaluation of patient survival post-procedure
Measured: 30 days
Device Deficiencies and Use Errors - Documentation of device-related malfunctions or improper usage
Documentation of device-related malfunctions or improper usage
Measured: 1 day
All Adverse Events - Monitoring of all minor and major adverse events related to surgery
Monitoring of all minor and major adverse events related to surgery
Measured: 30 days
Device Performance Metrics - Assessment of unplanned instrument usage, robotic arm clashes, collision detection, and system-generated alarms
Assessment of unplanned instrument usage, robotic arm clashes, collision detection, and system-generated alarms
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study startMay 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue SurgeriesStudies 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
- Retrospective
- Enrolment
- 365 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sudhir Srivastava Innovations Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clicebo Solutions Private Limited
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Somashekhar S P, MBBS, MS, MCh, FRCS, FRCS, Principal investigator, Aster CMI Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974955
- Sponsor's protocol ID
- CSPL/REG/2025/01
- Acronym
- MARS
- Status last verified
- May 2025
- First submitted
- 3 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stoianovici DC, Patriciu A, Mazilu D, et al. AcuBot: a robot for radiological interventions. IEEE Trans Rob Autom. 2003; 19: 926-30.
Gomez G. Sabiston Textbook of Surgery. 17th ed. Philadelphia, Pa: Elsevier Saunders; 2004. Emerging Technology in surgery: informatics, electronics, robotics.
US Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff. Food and Drug Administration. 2017 Aug 31
Hutchinson A. The top 50 inventions of the past 50 years. Popular Mechanics. December 2005.
Boctor EM, Choti MA, Burdette EC, Webster Iii RJ. Three-dimensional ultrasound-guided robotic needle placement: an experimental evaluation. Int J Med Robot. 2008 Jun;4(2):180-91. doi: 10.1002/rcs.184.
PubMed 18433079Cadeddu JA, Bzostek A, Schreiner S, Barnes AC, Roberts WW, Anderson JH, Taylor RH, Kavoussi LR. A robotic system for percutaneous renal access. J Urol. 1997 Oct;158(4):1589-93.
PubMed 9302179Harris SJ, Arambula-Cosio F, Mei Q, Hibberd RD, Davies BL, Wickham JE, Nathan MS, Kundu B. The Probot--an active robot for prostate resection. Proc Inst Mech Eng H. 1997;211(4):317-25. doi: 10.1243/0954411971534449.
PubMed 9330543Tan GY, Goel RK, Kaouk JH, Tewari AK. Technological advances in robotic-assisted laparoscopic surgery. Urol Clin North Am. 2009 May;36(2):237-49, ix. doi: 10.1016/j.ucl.2009.02.010.
PubMed 19406324Kazanzides P, Fichtinger G, Hager GD, Okamura AM, Whitcomb LL, Taylor RH. Surgical and Interventional Robotics: Core Concepts, Technology, and Design. IEEE Robot Autom Mag. 2008 Jun 1;15(2):122-130. doi: 10.1109/MRA.2008.926390. No abstract available.
PubMed 20428333Sim HG, Yip SK, Cheng CW. Equipment and technology in surgical robotics. World J Urol. 2006 Jun;24(2):128-35. doi: 10.1007/s00345-006-0070-6. Epub 2006 Mar 15.
PubMed 16538515H. Lavery, D. Samadi, and A. Levinson, "Not a zerosum game: the adoption of robotics has increased overall prostatectomy utilization in the united states," in Proceedings of the American Urological Association Annual Meeting, Poster Session,Washington, DC, USA, 2011.
Hashizume M, Tsugawa K. Robotic surgery and cancer: the present state, problems and future vision. Jpn J Clin Oncol. 2004 May;34(5):227-37. doi: 10.1093/jjco/hyh053.
PubMed 15231856Camarillo DB, Krummel TM, Salisbury JK Jr. Robotic technology in surgery: past, present, and future. Am J Surg. 2004 Oct;188(4A Suppl):2S-15S. doi: 10.1016/j.amjsurg.2004.08.025.
PubMed 15476646Marohn MR, Hanly EJ. Twenty-first century surgery using twenty-first century technology: surgical robotics. Curr Surg. 2004 Sep-Oct;61(5):466-73. doi: 10.1016/j.cursur.2004.03.009.
PubMed 15475097Ballantyne GH. The pitfalls of laparoscopic surgery: challenges for robotics and telerobotic surgery. Surg Laparosc Endosc Percutan Tech. 2002 Feb;12(1):1-5. doi: 10.1097/00129689-200202000-00001.
PubMed 12008756
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World, Multicenter, Retrospective Study to Evaluate the Clinical Performance and Safety of MantraTM Surgical Robotic System for Soft Tissue Surgeries
- ClinicalTrials.gov ID
- NCT06974955
- Acronym / sponsor ID
- MARS / CSPL/REG/2025/01
- Conditions
- Soft Tissue Surgeries
- Keywords
- Retrospective Study, Real World, Mantra TM Surgical Robotic System, soft tissue surgeries
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 365 participants (estimated)
- Lead sponsor
- Sudhir Srivastava Innovations Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Clicebo Solutions Private Limited
- Study start
- May 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 16 May 2025 (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.
A Real-World, multicentre retrospective study to evaluate the clinical performance and safety of MantraTM Surgical Robotic System for soft tissue surgeries.
The purpose of this retrospective study is to evaluate the clinical performance and safety of the Mantra™ Surgical Robotic System, Model 3.0, for soft tissue surgeries. It aims to provide real-world evidence on the system's reliability, safety, and effectiveness in the real world population. The SSI Mantra 3.0 Surgical Robotic System is an advanced, modular, and cost-effective robotic-assisted surgical platform designed to enhance precision, flexibility, and control in minimally invasive surgeries (MIS).
The objective of this retrospective study is to assess the clinical performance and safety of the Mantra™ Surgical Robotic System in performing various soft tissue surgeries based on retrospective data analysis.
Detailed description
A Real-World, multicentre retrospective study to evaluate the clinical performance and safety of MantraTM Surgical Robotic System for soft tissue surgeries.
Objective : To assess the clinical performance and safety of the Mantra™ Surgical Robotic System in performing various soft tissue surgeries based on retrospective data analysis.
Study Outcomes: The retrospective analysis of the Mantra Surgical Robotic System focused on evaluating its clinical performance, safety and efficacy in minimally invasive surgeries. The study outcomes were assessed based on surgical safety and efficacy parameters, intraoperative efficiency, post-operative recovery, and system utilization trends.
Primary Study Outcomes
- Primary Effectiveness Endpoint
- Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP).
- Successful completion of the procedure using the SSI Mantra 3.0 Surgical Robotic System as planned.
- Primary Safety Endpoint
- Rate of Total Intraoperative and Postoperative Serious Adverse Events (SAE) up to 30 days post-procedure.
- Assessment of device-related complications . Secondary Study Outcomes
- Operative Time
- Measured from skin incision to skin closure to assess efficiency. 2. Estimated Blood Loss (Intraoperative)
- Quantification of blood loss during surgery. 3. Need for Blood Transfusion
- Evaluation of cases requiring intraoperative blood transfusion. 4. Intraoperative Complications
- Identification and classification of adverse events occurring during surgery. 5. Return to Operating Room within 24 Hours
- Evaluation of unplanned reoperations. 6. Length of Hospital Stay
- Time from hospital admission to discharge post-surgery. 7. Readmission to Hospital within 30 Days
- Tracking of unexpected hospital readmissions. 8. Reoperation within 30 Days
- Incidence of repeat surgical interventions. 9. Mortality Rate at 30 Days
- Evaluation of patient survival post-procedure. 10. Device Deficiencies and Use Errors
- Documentation of device-related malfunctions or improper usage. 11. All Adverse Events
- Comprehensive assessment of both minor and major adverse effects. 12. Device Performance Data
- Monitoring of unplanned instrument usage, system clashes, collision detection, and alarm activations.
Timepoints: Day of surgery - 30 days (follow-up). Study Design: This is a retrospective, multicentre study designed to collect and analyze data from surgeries performed using the Mantra™ Surgical Robotic System, Models 3.0,. The study will evaluate clinical performance, safety, and patient outcomes across approximately twenty centers with a target sample size of 365 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have previously undergone surgery using the Mantra™ Surgical Robotic System 3.0 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include patients who have undergone soft tissue surgeries using the Mantra™ Surgical Robotic System (3.0)
Key inclusion criteria (2 listed)
- Participants must meet all of the following criteria to be eligible for inclusion in this retrospective clinical study of the SSI Mantra 3.0 Surgical Robotic System.
- Patients who have previously undergone surgery using the Mantra™ Surgical Robotic System (Model 3.0) for the following procedures mentioned in Appendix D
Key exclusion criteria (1 listed)
- Patients with missing data on primary endpoints.
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
Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP)
Time frame: 1 day
• Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP).
Successful completion of procedures without the need for conversion
Time frame: 1 day
Successful completion of procedures without the need for conversion
Rate of intraoperative and postoperative serious adverse events (SAEs) occurring up to 30 days post-procedure
Time frame: 30 days
Rate of intraoperative and postoperative serious adverse events (SAEs) occurring up to 30 days post-procedure
Evaluation of surgical complications, including infections, haemorrhage, and device-related adverse events
Time frame: 30 day
Evaluation of surgical complications, including infections, haemorrhage, and device-related adverse events
12 secondary outcomes
Operative Time - Measured from skin incision to skin closure to assess efficiency
Time frame: 1 day
Estimated Blood Loss (Intraoperative) - Quantification of Blood loss during surgery
Time frame: 1 day
Need for Blood Transfusion - Evaluation of cases requiring intraoperative blood transfusion
Time frame: 1 day
Intraoperative Complications - Identification and classification of adverse events occurring during surgery
Time frame: 1 day
Return to Operating Room within 24 Hours - Evaluation of unplanned reoperations
Time frame: 1 day
Length of Hospital Stay - Time from hospital admission to discharge post-surgery
Time frame: 30 days
Readmission to Hospital within 30 Days - Tracking of unexpected hospital readmissions
Time frame: 30 days
Reoperation within 30 Days - Incidence of repeat surgical interventions
Time frame: 30 days
Mortality Rate at 30 Days - Evaluation of patient survival post-procedure
Time frame: 30 days
Device Deficiencies and Use Errors - Documentation of device-related malfunctions or improper usage
Time frame: 1 day
All Adverse Events - Monitoring of all minor and major adverse events related to surgery
Time frame: 30 days
Device Performance Metrics - Assessment of unplanned instrument usage, robotic arm clashes, collision detection, and system-generated alarms
Time frame: 1 day
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 16 May 2025.
- BackgroundStoianovici DC, Patriciu A, Mazilu D, et al. AcuBot: a robot for radiological interventions. IEEE Trans Rob Autom. 2003; 19: 926-30.
- BackgroundGomez G. Sabiston Textbook of Surgery. 17th ed. Philadelphia, Pa: Elsevier Saunders; 2004. Emerging Technology in surgery: informatics, electronics, robotics.
- BackgroundUS Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff. Food and Drug Administration. 2017 Aug 31
- BackgroundHutchinson A. The top 50 inventions of the past 50 years. Popular Mechanics. December 2005.
- Background: PubMed 18433079Boctor EM, Choti MA, Burdette EC, Webster Iii RJ. Three-dimensional ultrasound-guided robotic needle placement: an experimental evaluation. Int J Med Robot. 2008 Jun;4(2):180-91. doi: 10.1002/rcs.184.
- Background: PubMed 9302179Cadeddu JA, Bzostek A, Schreiner S, Barnes AC, Roberts WW, Anderson JH, Taylor RH, Kavoussi LR. A robotic system for percutaneous renal access. J Urol. 1997 Oct;158(4):1589-93.
- Background: PubMed 9330543Harris SJ, Arambula-Cosio F, Mei Q, Hibberd RD, Davies BL, Wickham JE, Nathan MS, Kundu B. The Probot--an active robot for prostate resection. Proc Inst Mech Eng H. 1997;211(4):317-25. doi: 10.1243/0954411971534449.
- Background: PubMed 19406324Tan GY, Goel RK, Kaouk JH, Tewari AK. Technological advances in robotic-assisted laparoscopic surgery. Urol Clin North Am. 2009 May;36(2):237-49, ix. doi: 10.1016/j.ucl.2009.02.010.
- Background: PubMed 20428333Kazanzides P, Fichtinger G, Hager GD, Okamura AM, Whitcomb LL, Taylor RH. Surgical and Interventional Robotics: Core Concepts, Technology, and Design. IEEE Robot Autom Mag. 2008 Jun 1;15(2):122-130. doi: 10.1109/MRA.2008.926390. No abstract available.
- Background: PubMed 16538515Sim HG, Yip SK, Cheng CW. Equipment and technology in surgical robotics. World J Urol. 2006 Jun;24(2):128-35. doi: 10.1007/s00345-006-0070-6. Epub 2006 Mar 15.
- BackgroundH. Lavery, D. Samadi, and A. Levinson, "Not a zerosum game: the adoption of robotics has increased overall prostatectomy utilization in the united states," in Proceedings of the American Urological Association Annual Meeting, Poster Session,Washington, DC, USA, 2011.
- Background: PubMed 15231856Hashizume M, Tsugawa K. Robotic surgery and cancer: the present state, problems and future vision. Jpn J Clin Oncol. 2004 May;34(5):227-37. doi: 10.1093/jjco/hyh053.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
Prof. Dr. Somashekhar S P, MBBS, MS, MCh, FRCS, FRCS principal investigator
Aster CMI Hospital
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 Soft Tissue Surgeries, run by Sudhir Srivastava Innovations Pvt. Ltd. at 1 site in India.
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 2 inclusion and 1 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 16 May 2025. 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 India. 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 Sonia Shokeen (91+9958002162, Sonia.shokeen@ssinnovations.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP) (time frame: 1 day). 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 NCT06974955, which also lists 15 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 16 May 2025.