Minimally invasive robotic-assisted surgery with Dexter for the removal of the uterus and adjacent connective tissue
Summary description of the study
This is a clinical study following the market launch of the surgical robotic medical device Dexter. The aim of the study is to confirm the safety and performance of the device. The surgical treatment and postoperative follow-up will be conducted after 30 days, which is not routinely possible in hospitals. The safety of the medical device is assessed by collecting data on whether any adverse events occurred during and after the surgery (up to 6 weeks post-surgery) that could be related to the use of the medical device.
(BASEC)
Intervention under investigation
Treatment of gynecological conditions through minimally invasive robotic surgery in hysterectomy with or without adnexectomy.
(BASEC)
Disease under investigation
The aim of this clinical study is to confirm the safety and clinical performance/effectiveness of the Dexter robotic system during and shortly after a robotic and laparoscopic hysterectomy with or without adnexectomy.
(BASEC)
• >18 years old • Patients for whom an elective robotic or laparoscopic hysterectomy with or without adnexectomy is planned. • The patient agrees to participate in the 6-week follow-up. (BASEC)
Exclusion criteria
• The person is pregnant (only women of childbearing age) • The person is morbidly obese • The person has a pacemaker or an internal defibrillator (BASEC)
Trial sites
Bern, Zurich, Other
(BASEC)
Unterseen, Baden
(BASEC)
Sponsor
Distalmotion SA
(BASEC)
Contact
Contact Person Switzerland
Alison Moran
+41 797565748
alison.moran@clutterdistalmotion.comDistalmotion SA
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
31.07.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
HYsterectomy with adnexal surgery Procedures with the DEXTER Robotic system (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available