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Clinical Investigation of the da Vinci Surgical System

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Intuitive Surgical

Status

Active, not recruiting

Conditions

Prostate Disease
Thymoma
Ventral Hernia
Pelvic Organ Prolapse
Gynecologic Cancer
Gynecologic Disease
Inguinal Hernia
Prostate Cancer
Mediastinal Tumor
Obesity, Morbid

Treatments

Device: Robotic-assisted Surgery

Study type

Interventional

Funder types

Industry

Identifiers

NCT05682742
1097341C

Details and patient eligibility

About

This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.

Enrollment

53 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Pre-operative Inclusion Criteria:

  • Age 21 years or older
  • Per study Investigator's discretion, subject is a suitable candidate to undergo multiport robotic-assisted surgery for the study specified procedure as a primary procedure

Pre-operative Exclusion Criteria:

  • Subject is pregnant or suspected to be pregnant or breastfeeding
  • Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data
  • Subject is currently participating in or has participated in a study of an investigational agent or a significant risk investigational device study within the past 6 months
  • Subject belongs to vulnerable population.
  • Subject is contraindicated for anesthesia or surgery
  • Subject has had previous neoadjuvant therapy, previous chemotherapy, immunotherapy, and/or radiation therapy for treatment of the cancer to be resected within the past 6 months

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

53 participants in 1 patient group

Robotic-assisted surgery
Experimental group
Description:
Subjects scheduled to undergo robotic-assisted surgery
Treatment:
Device: Robotic-assisted Surgery

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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