HysterectomyNCT05537727
Robotic MIS With Dexter
An observational study of Hysterectomy and Partial Nephrectomy, run by Distalmotion SA at 5 sites in 3 countries.
Trial summary
The purpose of this study is to confirm the perioperative and early postoperative safety and clinical performance of the Dexter Robotic System (Dexter Surgical System, Model DM-L6). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hysterectomy, Partial Nephrectomy, Right Colectomy
- What is being tested?
- robotic-assisted surgery
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 27 Sep 2022to 9 Jan 2025
- 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: The study population will consist of the modified intent-to-treat (mITT) sample. This is defined as the set of patients who were enrolled in the trial and on whom robotic-assisted surgery with Dexter was at least started.
Who may be able to join
- Aged ≥ 18 years
- Patient agrees to perform the 30-day follow-up assessment
- Able to provide signed Informed Consent, according to local regulation
Who cannot join
- Morbidly obese patients.
- Any and all relative and absolute contraindications to endoscopic surgical technique applicable to the use of conventional endoscopic surgical instruments.
- Bleeding diathesis.
- Pregnancy.
- Patients with pacemakers or internal defibrillators.
- 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
5 sites in 3 countries.
5 sites in 3 countries
France2 sites
Hopital Paris Saint-Joseph
Paris
Centre Hospitalier de Saintes
Saintes
About this study
Official title: Robotic Minimally Invasive Gynecological, Urological, and General Surgery With Dexter
The purpose of this study is to confirm the perioperative and early postoperative safety and clinical performance of the Dexter Robotic System (Dexter Surgical System, Model DM-L6).
- Conditions
- Hysterectomy, Partial Nephrectomy, Right Colectomy
- Being tested
- robotic-assisted surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic-assisted surgeryDevice
Gynecology: robot-assisted and laparoscopic hysterectomy for benign or low risk malignant disease
robotic-assisted surgeryDevice
Urology: robot-assisted and laparoscopic partial nephrectomy
robotic-assisted surgeryDevice
General surgery: robot-assisted and laparoscopic right colectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of serious (Clavien - Dindo grades III-V), device related adverse events.
Measured: perioperatively up to 30 days
successful completion of the Dexter-assisted procedure, i.e. free of any device related permanent 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 posted13 Sep 2022
- Study start27 Sep 2022
- Primary completion9 Jan 2025
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Distalmotion SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dieter Hahnloser, MD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537727
- Sponsor's protocol ID
- 2021-01
- Status last verified
- Feb 2025
- First submitted
- 8 Sep 2022
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pochhammer J, Becker T, Grass F, Mignot H, Hahnloser D. Robotic-assisted right colectomy with the DEXTER(R) Robotic Surgery System: first prospective multicenter study. Tech Coloproctol. 2026 Jul 5;30(1):90. doi: 10.1007/s10151-026-03385-7.
PubMed 42402497
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Minimally Invasive Gynecological, Urological, and General Surgery With Dexter
- ClinicalTrials.gov ID
- NCT05537727
- Acronym / sponsor ID
- 2021-01
- Conditions
- Hysterectomy, Partial Nephrectomy, Right Colectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Distalmotion SAIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 13 Sep 2022 (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 study is to confirm the perioperative and early postoperative safety and clinical performance of the Dexter Robotic System (Dexter Surgical System, Model DM-L6).
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
- The study population will consist of the modified intent-to-treat (mITT) sample. This is defined as the set of patients who were enrolled in the trial and on whom robotic-assisted surgery with Dexter was at least started.
Key inclusion criteria (3 listed)
- Aged ≥ 18 years
- Patient agrees to perform the 30-day follow-up assessment
- Able to provide signed Informed Consent, according to local regulation
Key exclusion criteria (8 listed)
- Morbidly obese patients.
- Any and all relative and absolute contraindications to endoscopic surgical technique applicable to the use of conventional endoscopic surgical instruments.
- Bleeding diathesis.
- Pregnancy.
- Patients with pacemakers or internal defibrillators.
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 surgeryGynecology: robot-assisted and laparoscopic hysterectomy for benign or low risk malignant disease | Device | – |
| robotic-assisted surgeryUrology: robot-assisted and laparoscopic partial nephrectomy | Device | – |
| robotic-assisted surgeryGeneral surgery: robot-assisted and laparoscopic right colectomy | Device | – |
Primary outcome
occurrence of serious (Clavien - Dindo grades III-V), device related adverse events.
Time frame: perioperatively up to 30 days
successful completion of the Dexter-assisted procedure, i.e. free of any device related permanent 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 20 Feb 2025.
- Derived from this study: PubMed 42402497Pochhammer J, Becker T, Grass F, Mignot H, Hahnloser D. Robotic-assisted right colectomy with the DEXTER(R) Robotic Surgery System: first prospective multicenter study. Tech Coloproctol. 2026 Jul 5;30(1):90. doi: 10.1007/s10151-026-03385-7.
- Individual participant dataSharing planned: Undecided
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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.
Dieter Hahnloser, MD principal investigator
CHUV
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hysterectomy and Partial Nephrectomy, run by Distalmotion SA at 5 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 8 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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Switzerland, Germany. 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?
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?
On the ClinicalTrials.gov record for NCT05537727, which also lists 1 linked publication.
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 20 Feb 2025.