Inguinal Hernia RepairRAS-AheadNCT05873582
Robotic Minimally Invasive Inguinal Hernia Repair With Dexter
An observational study of Inguinal Hernia Repair, run by Distalmotion SA at 3 sites in 3 countries.
Trial summary
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia Repair
- What is being tested?
- Robotic-assisted inguinal hernia repair
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 2 Jun 2023to 23 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: adult patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair
Who may be able to join
- Aged > 18 years
- Patients planned to undergo elective robot-assisted and laparoscopic surgery for primary unilateral or bilateral inguinal hernia repair using one camera port, two ports for the manipulating instruments, and additional ports as needed.
- Able to provide Informed Consent according to local regulation
Who cannot join
- Morbidly obese patients (BMI > 40)
- Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
- Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
- Bleeding diathesis
- Pregnancy
- Patients with pacemakers or internal defibrillators
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- Any planned concomitant procedures
- Patient deprived of liberty by administrative or judicial decision or under legal guardianship
- Participation in another interventional clinical trial
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair.
- Conditions
- Inguinal Hernia Repair
- Being tested
- Robotic-assisted inguinal hernia repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted inguinal hernia repairDevice
Primary transperitoneal unilateral or bilateral inguinal hernia repair with the Dexter robotic system
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: occurrence of serious (Clavien - Dindo grades III-V), device-related, adverse events
Measured: perioperatively up to 30 days
Performance: 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 posted24 May 2023
- Study start2 Jun 2023
- Primary completion23 Oct 2023
- Study completion23 Oct 2023
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Distalmotion SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Confinis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873582
- Sponsor's protocol ID
- 2023-01
- Acronym
- RAS-Ahead
- Status last verified
- Jan 2024
- First submitted
- 15 May 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Minimally Invasive Inguinal Hernia Repair With Dexter
- ClinicalTrials.gov ID
- NCT05873582
- Acronym / sponsor ID
- RAS-Ahead / 2023-01
- Conditions
- Inguinal Hernia Repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Distalmotion SAIndustry (pharma, biotech, devices)
- Collaborators
- Confinis
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 24 May 2023 (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.
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair
Key inclusion criteria (3 listed)
- Aged > 18 years
- Patients planned to undergo elective robot-assisted and laparoscopic surgery for primary unilateral or bilateral inguinal hernia repair using one camera port, two ports for the manipulating instruments, and additional ports as needed.
- Able to provide Informed Consent according to local regulation
Key exclusion criteria (9 listed)
- Morbidly obese patients (BMI > 40)
- Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
- Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
- Bleeding diathesis
- Pregnancy
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 |
|---|---|---|
| Robotic-assisted inguinal hernia repairPrimary transperitoneal unilateral or bilateral inguinal hernia repair with the Dexter robotic system | Device | – |
Primary outcome
Safety: occurrence of serious (Clavien - Dindo grades III-V), device-related, adverse events
Time frame: perioperatively up to 30 days
Performance: successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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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.
3 sites in 3 countries: 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 3 sites in 3 countries.
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 9 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: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Germany, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety: occurrence of serious (Clavien - Dindo grades III-V), device-related, adverse events (time frame: perioperatively up to 30 days). 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 5 Jan 2024.