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Clinical Trials/CTRI/2024/06/068556
CTRI/2024/06/068556
Recruiting
N/A

A prospective non-randomised pilot clinical study to evaluate the safety, feasibility, and efficacy of MantraTM Surgical Robotic System, Model 3.0 in the predetermined surgical procedures. - NO

Sudhir Srivastava Innovations Pvt. Ltd0 sites0 target enrollmentTBD
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Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Sudhir Srivastava Innovations Pvt. Ltd
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Sudhir Srivastava Innovations Pvt. Ltd

Eligibility Criteria

Inclusion Criteria

  • •Male or Female patients with age of eighteen (18\) and above.
  • •Able to give written informed consent.
  • •Patients meeting the inclusion criteria for one of the following surgical procedures using MantraTM Surgical Robotic System, Model 3\.0 for soft tissue surgeries:
  • •Cholecystectomy
  • •Hysterectomy
  • •Nephrectomy
  • •Prostatectomy
  • •Oesophagus mobilization
  • •Internal Mammary Artery takedown
  • •Lung Lobectomy

Exclusion Criteria

  • •Patients who have participated in another investigational clinical study within thirty (30\) days before screening
  • •Inability to provide informed consent
  • •Uncontrolled Comorbidities such as hypertension, diabetes mellitus or any other co\-morbidities that is considered as a high risk for the planned surgical procedure
  • •Patients who fall into New York Heart Association (NYHA) Class III or IV
  • •History of chronic alcohol or drug abuse.
  • •Chronic renal failure or on dialysis.
  • •Subjects with any other clinically significant unstable medical condition, life\-threatening disease, or anything else in the opinion of the Investigator that would contra\-indicate a surgical procedure.

Outcomes

Primary Outcomes

Not specified

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