The da Vinci Single Port Robotic System for Use in Abdominal and Pelvic Surgical Procedures
ConditionDisease or Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center
About this trial
This phase II trial test the effectiveness and safety of a single-port robotic device (the da Vinci single port \[SP\]1098) for use in abdominal and pelvic surgeries. The da Vinci SP1098 robotic device can be used to perform less invasive surgeries that allow entry into the body through a single, small incision. The use of this device during surgery may allow surgeons to perform complex procedures that result in less pain, fewer complications and side effects, and improved recovery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented informed consent of the participant and/or legally authorized representative
Any patient scheduled to undergo robot-assisted abdominal or pelvic procedures
Age > 18 years
Disqualifiers
Body mass index (BMI) > 45
Contraindications to minimally invasive surgery including chronic obstructive pulmonary disorders
Past history of failed attempt of minimally invasive abdominal or pelvic surgery
Trial design
Design model
Single group
Treatments tested in this trial
Robot-Assisted Surgery
DeviceUndergo surgery using the da Vinci SP device
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Device feasibility (da Vinci SP1098 robotic system)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Conversion of operation to laparotomy
The number and frequency will be reported with 95% confidence intervals.
Time frame
Within 30 days of operation2
Incidence of major surgical complications
Will be assessed by Clavien-Dindo classification as grade 3 or higher. The number and frequency will be reported with 95% confidence intervals.
Time frame
Within 30 days of operationSponsors and contacts
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov