SurgeryminiTRUSTNCT07081828
The Asensus Paediatric Robotic Registry
An observational study of Surgery and Surgery in Early Childhood, run by Asensus Surgical at 1 site in Germany.
Trial summary
An open-label, observational, paediatric registry trial in which participating centers enroll subjects who had or will have a laparoscopically-assisted surgery using the Senhance Surgical System. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Surgery, Surgery in Early Childhood
- What is being tested?
- Surgery
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- 17 Jun 2025to 4 Aug 2026
- How long will I take part?
- 3 Months
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Paediatric patients at a participating center who have had or are scheduled to have surgery using the Senhance system
Who may be able to join
- < 18 years of age
- Body weight > 10 kg
- Indication for a potential robot-assisted operation
- Expected survival of > 3 months
Who cannot join
- Subjects requiring surgery on the heart or greater vessels.
- Subjects for whom a laparoscopic approach and endoscopic approach in the thoracic area is not appropriate.
- Anaesthetic contraindications, children with pacemakers or other implants for which electrosurgery must be avoided, children with cancer, parents who prefer to proceed with classical or manual laparoscopic surgery.
- Subjects pregnant over the second trimester of pregnancy.
- Parents or children with insufficient understanding of the site's local language (e.g. Dutch, German) or English language.
- Presence of any relevant severe condition or clinically relevant abnormal laboratory parameters due to which an endoscopic or laparoscopic surgical technique is contraindicated.
- Subjects who would require an intervention to the upper mediastinum or to the upper pleural cavity regions as referred in the Senhance Surgical System User Manual (UM-001-00035_CE).
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dr. von Hauner Children's Hospital Clinic of the University of Munich
München
About this study
Official title: The Asensus Paediatric Registry of Robotic-Assisted Endoscopic Procedures in Urology, Gynaecology, and General Surgery
An open-label, observational, paediatric registry trial in which participating centers enroll subjects who had or will have a laparoscopically-assisted surgery using the Senhance Surgical System.
Read the detailed description
This is a prospective and retrospective, multi-center, observational registry study evaluating the use of the Senhance Surgical System in paediatric patients undergoing laparoscopically-assisted surgery. The trial is open-label and designed to collect both historical and prospective data from participating centers. Paediatric subjects who have undergone or will undergo procedures with the Senhance Surgical System will be enrolled. The primary purpose for this study is to assess safety outcomes. Secondary endpoints include length of hospital stay, procedural information, and patient-reported outcomes.
- Conditions
- Surgery, Surgery in Early Childhood
- Being tested
- Surgery
- Keywords
- Robotic, Laparoscopic, Senhance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryDevice
Patients who undergo surgery utilising the Senhance Surgical System.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Rate of Adverse Event (Clavien >3)
Measured: Index surgery to 30 days postoperative
Procedure-related severe adverse event
Percent of procedurally related SAE after adjudication
Measured: Index surgery to 30 days post-operative
Secondary outcomes (5)
Length of Stay
Total duration (in days) of hospitalization related to the index surgical procedure
Measured: From day of index procedure to hospital discharge, up to 2 weeks
Conversion to unplanned open surgery
Rate of unplanned conversions from laparoscopic to open surgery.
Measured: Intraoperative (during index surgical procedure)
COMFORT-B scale for assessing pain in pediatric patients aged 0 to less than 2 years of age
The COMFORT-B Score is a validated behavioral assessment tool designed to evaluate the level of sedation, pain, and distress in pediatric patients. The COMFORT-B scale will be used to assess pain levels in children aged 0 to less than 2 years of age. The COMFORT-B scale includes six behavioral dimensions: Alertness, Calmness/Agitation, Respiratory Response (only in mechanically ventilated children), Crying (only in spontaneously breathing children), Physical Movement, Muscle Tone, and Facial Tension. Each dimension is scored on a scale from 1 to 5, yielding a total score range of 6 to 30. Higher scores indicate greater distress or discomfort.
Measured: Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.
Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale for children aged 2 years to less than 7 years of age.
The FLACC scale assesses pain by observing five categories of behaviors and assigning a score of 0-2 to each category, resulting in a total score of 0-10, where a score of 10 indicates a higher level of pain.
The following five behavioral categories are assessed: Facial expression, leg movement, Activity level, Crying, and Consolability.
The FLACC scale will be utilized to assess pain in children aged 2 to less than 7 years of age.
Measured: Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.
Numerical Rating Scale (NRS) for assessing pain in patients aged 7 years to less than 18 years of age.
Pain will be assessed using a numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain). The NRS scale will be used for patients aged 7 years to less than 18 years of age.
Measured: Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start17 Jun 2025
- Primary completion4 Aug 2026
- Study completion4 Aug 2026
Why it stopped: Terminated due to a business decision by the acquiring company to discontinue the marketed product. The post-market surveillance registry was no longer feasible. Not related to safety concerns.
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 SurgeryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Asensus Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RQM+
- Responsible party
- Sponsor
- Investigators
- Jan Gödeke, Dr. med., Principal investigator, Dr. von Hauner Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081828
- Sponsor's protocol ID
- miniTRUST
- Acronym
- miniTRUST
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Killaars REM, Visschers RGJ, Cakir H, Dinjens DJA, Widmann DL, Friedrich H, Muensterer O, van Gemert WG, Goedeke J; MiniTrust Collaborative Study Group. Robotic-assisted endoscopic procedures in paediatric urology, gynaecology and general surgery: protocol for a multicenter observational registry study (MiniTrust study). BMJ Open. 2026 Mar 26;16(3):e110106. doi: 10.1136/bmjopen-2025-110106.
PubMed 41887639
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Asensus Paediatric Registry of Robotic-Assisted Endoscopic Procedures in Urology, Gynaecology, and General Surgery
- ClinicalTrials.gov ID
- NCT07081828
- Acronym / sponsor ID
- miniTRUST / miniTRUST
- Conditions
- Surgery, Surgery in Early Childhood
- Keywords
- Robotic, Laparoscopic, Senhance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to a business decision by the acquiring company to discontinue the marketed product. The post-market surveillance registry was no longer feasible. Not related to safety concerns.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Asensus SurgicalIndustry (pharma, biotech, devices)
- Collaborators
- RQM+
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 4 Aug 2026 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 23 Jul 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.
An open-label, observational, paediatric registry trial in which participating centers enroll subjects who had or will have a laparoscopically-assisted surgery using the Senhance Surgical System.
Detailed description
This is a prospective and retrospective, multi-center, observational registry study evaluating the use of the Senhance Surgical System in paediatric patients undergoing laparoscopically-assisted surgery. The trial is open-label and designed to collect both historical and prospective data from participating centers. Paediatric subjects who have undergone or will undergo procedures with the Senhance Surgical System will be enrolled. The primary purpose for this study is to assess safety outcomes. Secondary endpoints include length of hospital stay, procedural information, and patient-reported outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Paediatric patients at a participating center who have had or are scheduled to have surgery using the Senhance system
Key inclusion criteria (4 listed)
- < 18 years of age
- Body weight > 10 kg
- Indication for a potential robot-assisted operation
- Expected survival of > 3 months
Key exclusion criteria (7 listed)
- Subjects requiring surgery on the heart or greater vessels.
- Subjects for whom a laparoscopic approach and endoscopic approach in the thoracic area is not appropriate.
- Anaesthetic contraindications, children with pacemakers or other implants for which electrosurgery must be avoided, children with cancer, parents who prefer to proceed with classical or manual laparoscopic surgery.
- Subjects pregnant over the second trimester of pregnancy.
- Parents or children with insufficient understanding of the site's local language (e.g. Dutch, German) or English language.
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 |
|---|---|---|
| SurgeryPatients who undergo surgery utilising the Senhance Surgical System. | Device | – |
Primary outcome
Adverse Event
Time frame: Index surgery to 30 days postoperative
Rate of Adverse Event (Clavien >3)
Procedure-related severe adverse event
Time frame: Index surgery to 30 days post-operative
Percent of procedurally related SAE after adjudication
5 secondary outcomes
Length of Stay
Time frame: From day of index procedure to hospital discharge, up to 2 weeks
Conversion to unplanned open surgery
Time frame: Intraoperative (during index surgical procedure)
COMFORT-B scale for assessing pain in pediatric patients aged 0 to less than 2 years of age
Time frame: Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.
Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale for children aged 2 years to less than 7 years of age.
Time frame: Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.
Numerical Rating Scale (NRS) for assessing pain in patients aged 7 years to less than 18 years of age.
Time frame: Day after index surgery to day of discharge from hospital for index surgery, up to 2 weeks.
Results and safety
The study was stopped early (reason given: Terminated due to a business decision by the acquiring company to discontinue the marketed product. The post-market surveillance registry was no longer feasible. Not related to safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Derived from this study: PubMed 41887639Killaars REM, Visschers RGJ, Cakir H, Dinjens DJA, Widmann DL, Friedrich H, Muensterer O, van Gemert WG, Goedeke J; MiniTrust Collaborative Study Group. Robotic-assisted endoscopic procedures in paediatric urology, gynaecology and general surgery: protocol for a multicenter observational registry study (MiniTrust study). BMJ Open. 2026 Mar 26;16(3):e110106. doi: 10.1136/bmjopen-2025-110106.
Related trials for Surgery
Not yet recruiting
The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases
mERAS Intervention, The ASA (American Society of Anesthesiologists) Score
RecruitingObservational study
Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Lung Cancer
RecruitingPhase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Ganglioneuroblastoma, Nodular, Neuroblastoma
Not yet recruiting
The Effect of Compound Chamomile and Lidocaine Hydronchloride Gel as an Endotracheal Tube Lubricant on Postoperative Pharyngeal and Laryngeal Complications in Thoracic Surgery Patients
Postoperative Sore Throat
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
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.
Jan Gödeke, Dr. med. principal investigator
Dr. von Hauner Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Surgery in Early Childhood, run by Asensus Surgical at 1 site in Germany.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 was stopped early (reason given: Terminated due to a business decision by the acquiring company to discontinue the marketed product. The post-market surveillance registry was no longer feasible. Not related to safety concerns.). Results are not available in the source record.
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?
Adverse Event (time frame: Index surgery to 30 days postoperative). 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 NCT07081828, 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 12 Aug 2026.