The da Vinci Single Port Robotic System for Use in Abdominal and Pelvic Surgical Procedures
Status and phase
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Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
PRIMARY OBJECTIVE:
I. To evaluate the effectiveness and safety for abdominal and pelvic procedures of a single-port robotic device (da Vinci SP1098) that is Food and Drug Administration (FDA)-approved for other indications, specifically urological and transoral otolaryngology surgical procedures.
OUTLINE:
Patients undergo surgery using the da Vinci SP1098 robotic system on study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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
Primary purpose
Allocation
Interventional model
Masking
33 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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