Inguinal Hernia RepairRAS-ACCESSNCT07181876
Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System
An observational study of Inguinal Hernia Repair, run by Distalmotion SA at 2 sites in United States.
Trial summary
The purpose of this post-market, observational study is to collect data under anticipated conditions of use that demonstrates that DEXTER performs as intended in the intended patient population, including a variety of representative disease etiologies and demographic groups. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Inguinal Hernia Repair
- What is being tested?
- inguinal hernia repair
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Nov 2025to Dec 2029
- 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: Adult patients undergoing unilateral or bilateral inguinal hernia repair
Who may be able to join
- Subject is ≥ 22 years of age at time of enrollment/consent
- Subject is indicated for and planned to undergo robot-assisted and laparoscopic surgery for unilateral or bilateral inguinal hernia repair
- Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form
Who cannot join
- Subject with any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments and/or general non-procedure specific contraindications to endoscopic surgery including bleeding diathesis and pregnancy
- Subject is participating in another clinical investigation at the time of enrollment or planned participation at any time during this clinical study
- Subject has a known or suspected medical condition that, in the opinion of the Investigator, may put the subject at risk for participation in this clinical study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Northtowns Ambulatory Surgical Center (NASC)
Buffalo, New York, 14221
- Recruiting
Memorial Hermann-Texas Medical Center - UT Health Houston
Houston, Texas, 77030
Jonah Stulberg, MD, +1 (713) 486-1330, jonha.j.stulberg@uth.tmc.edu
About this study
The purpose of this post-market, observational study is to collect data under anticipated conditions of use that demonstrates that DEXTER performs as intended in the intended patient population, including a variety of representative disease etiologies and demographic groups.
- Conditions
- Inguinal Hernia Repair
- Being tested
- inguinal hernia repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inguinal hernia repairDevice
Robotic-assisted inguinal hernia repair with the DEXTER robotic surgery system
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety outcome
Occurrence of Clavien-Dindo grades III-V adverse events
Measured: up to 30 days after surgery
Primary efficacy outcome
Successful completion of the DEXTER-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start26 Nov 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia RepairStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Distalmotion SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veranex, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181876
- Sponsor's protocol ID
- 2025-03
- Acronym
- RAS-ACCESS
- Status last verified
- Jul 2026
- First submitted
- 12 Sep 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System
- ClinicalTrials.gov ID
- NCT07181876
- Acronym / sponsor ID
- RAS-ACCESS / 2025-03
- Conditions
- Inguinal Hernia Repair
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Distalmotion SAIndustry (pharma, biotech, devices)
- Collaborators
- Veranex, Inc.
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 18 Sep 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 purpose of this post-market, observational study is to collect data under anticipated conditions of use that demonstrates that DEXTER performs as intended in the intended patient population, including a variety of representative disease etiologies and demographic groups.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing unilateral or bilateral inguinal hernia repair
Key inclusion criteria (3 listed)
- Subject is ≥ 22 years of age at time of enrollment/consent
- Subject is indicated for and planned to undergo robot-assisted and laparoscopic surgery for unilateral or bilateral inguinal hernia repair
- Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form
Key exclusion criteria (3 listed)
- Subject with any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments and/or general non-procedure specific contraindications to endoscopic surgery including bleeding diathesis and pregnancy
- Subject is participating in another clinical investigation at the time of enrollment or planned participation at any time during this clinical study
- Subject has a known or suspected medical condition that, in the opinion of the Investigator, may put the subject at risk for participation in this clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inguinal hernia repairRobotic-assisted inguinal hernia repair with the DEXTER robotic surgery system | Device | – |
Primary outcome
Primary safety outcome
Time frame: up to 30 days after surgery
Occurrence of Clavien-Dindo grades III-V adverse events
Primary efficacy outcome
Time frame: Intraoperative
Successful completion of the DEXTER-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
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 6 Jul 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia Repair, run by Distalmotion SA at 2 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?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Pascal Lehmann (+41215105890, pascal.lehmann@distalmotion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety outcome (time frame: up to 30 days after surgery). The study lists 2 primary outcomes in all. 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 6 Jul 2026.