Hernia, InguinalNCT06879912
A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot
An observational study of Hernia, Inguinal and Hernia, Ventral, run by Intuitive Surgical at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hernia, Inguinal, Hernia, Ventral, Colorectal
- How many people
- 200 participants
- Where
- 6 sitesUnited States
- Study dates
- 24 May 2025to Jan 2027
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Pre-Operative Inclusion Criteria:
- 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
- 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 Exclusion Criteria
- Subject with hemodynamic or respiratory instability, which precludes the Investigator from performing the RAS.
- Subject in whom inadequate visualization makes a minimally invasive approach not feasible, as determined from the investigator assessment prior to docking the robot.
- Subject with adhesions, scarring and disease status in the body which in the opinion of the investigator limits the ability to perform the minimally invasive procedure.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
St. David's Healthcare
Austin, Texas, 78758
Northwestern Memorial Healthcare
Chicago, Illinois, 60611
Ohio State University
Columbus, Ohio, 43210
Northeast Georgia Medical Center, Inc
Gainesville, Georgia, 30501
University of Miami
Miami, Florida, 33136
Sharp Memorial Hospital
San Diego, California, 92123
About this study
Official title: 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
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.
- Conditions
- Hernia, Inguinal, Hernia, Ventral, Colorectal, Thoracic, Gynecologic, Partial Nephrectomy
- Medical subject headings
- Hernia, Inguinal, Hernia, Ventral
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the force imparted on the tissue by force feedback instruments.
Measured: Intra-operative
Secondary outcomes (1)
To evaluate the utility of force feedback instruments during specific procedural steps or tasks.
Measured: Post-operative prior to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start24 May 2025
- Primary completion19 Aug 2026
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879912
- Sponsor's protocol ID
- ISI-dV5-MP-01
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06879912
- Acronym / sponsor ID
- ISI-dV5-MP-01
- Conditions
- Hernia, Inguinal, Hernia, Ventral, Colorectal, Thoracic, Gynecologic, Partial Nephrectomy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 24 May 2025 (actual)
- Primary completion
- 19 Aug 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 17 Mar 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
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
To assess the force imparted on the tissue by force feedback instruments.
Time frame: Intra-operative
1 secondary outcome
To evaluate the utility of force feedback instruments during specific procedural steps or tasks.
Time frame: Post-operative prior to discharge
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 4 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Inguinal and Hernia, Ventral, run by Intuitive Surgical at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the force imparted on the tissue by force feedback instruments. (time frame: Intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2026.