The da Vinci Single Port Robotic System for Use in Abdominal and Pelvic Surgical Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robot-Assisted Surgery.
- Who it may be relevant to
- Registry conditions: Disease or Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase II Study of the Da Vinci Single Port (SP) Robotic System for Abdominal and Pelvic Procedures
Overview
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.
Detailed 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.
Interventions
- Device Robot-Assisted Surgery
Undergo surgery using the da Vinci SP device
Primary outcome measures
- Conversion of operation to laparotomy [Time frame: Within 30 days of operation]
- Incidence of major surgical complications [Time frame: Within 30 days of operation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- City of Hope Comprehensive Cancer Center — Duarte
Identifiers
NCT: NCT05672368 · 22446 · NCI-2022-10346 · 22446 · P30CA033572