A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorIntuitive Surgical
About this trial
The goal of this observational study is to understand the utility of force feedback instruments in surgeries that are done using the da Vinci 5 robot.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 22 years or older
ASA ≤ 3
The clinical decision has been made to perform multi-port robotic assisted surgery with da Vinci 5 with Force Feedback instruments for the study specified procedure as primary procedure prior to enrollment in the study
Subject or a legally authorized representative is able to provide written informed consent using the study informed consent form prior to the study
Disqualifiers
Subject receiving an emergent procedure
Subject planned to undergo major concomitant surgery for the treatment of a different medical condition than was originally planned
Subject with previous ipsilateral surgery (open, endoscopic or robotic) with the same surgical indication
Subject with past or ongoing medical conditions (for example: inflammatory bowel disease) which, in the judgment of the Investigator, puts them at high risk for surgery and not appropriate for the study
Trial population
Subjects who will undergo the study specified procedure as primary procedure with da Vinci 5 robot and who meet all eligibility criteria will be considered for enrollment.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
To assess the force imparted on the tissue by force feedback instruments.
Time frame
Intra-operativeSecondary outcomes
1
To evaluate the utility of force feedback instruments during specific procedural steps or tasks.
Time frame
Post-operative prior to dischargeSponsors and contacts
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Source ClinicalTrials.gov