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A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot

A Prospective, Post-Market Study to Evaluate the Clinical Utility of the Force Feedback Instruments in RAS Procedures Using the da Vinci 5 Surgical System

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06879912
Enrollment
200
Registered
2025-03-17
Start date
2025-05-24
Completion date
2027-01-01
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal, Gynecologic, Hernia, Inguinal, Hernia, Ventral, Partial Nephrectomy, Thoracic

Brief summary

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.

Interventions

None listed

Sponsors

Intuitive Surgical
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Pre-Operative Inclusion Criteria: 1. Age 22 years or older 2. ASA ≤ 3 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 4. Subject or a legally authorized representative is able to provide written informed consent using the study informed consent form prior to the study 5. Subject is willing and able to comply with the study protocol requirements including follow up schedule Pre-operative

Exclusion criteria

* 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 * 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 a vulnerable population. * Subject is contraindicated for anesthesia or surgery. Intra-operative

Design outcomes

Primary

MeasureTime frame
To assess the force imparted on the tissue by force feedback instruments.Intra-operative

Secondary

MeasureTime frame
To evaluate the utility of force feedback instruments during specific procedural steps or tasks.Post-operative prior to discharge

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026