Using a robotic system for less invasive abdominal and pelvic surgeries
Phase II Study of the Da Vinci Single Port (SP) Robotic System for Abdominal and Pelvic Procedures
This study is testing a new robotic system for abdominal and pelvic surgeries to see if it can make recovery easier and safer for patients compared to traditional surgery methods.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT05672368 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the safety and effectiveness of the da Vinci single port robotic device (SP1098) for performing abdominal and pelvic surgeries. The device allows surgeons to conduct complex procedures through a single small incision, potentially leading to less pain, fewer complications, and improved recovery times for patients. Participants will undergo surgery using this robotic system, which is FDA-approved for other surgical indications. The study aims to gather data on the outcomes of these procedures compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for robot-assisted abdominal or pelvic procedures.
Not a fit: Patients with a BMI over 45 or contraindications to minimally invasive surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to less invasive surgical options with improved recovery for patients undergoing abdominal and pelvic surgeries.
How similar studies have performed: Other studies using robotic systems for minimally invasive surgeries have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Duarte, California
- City of Hope Comprehensive Cancer Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Mehdi Moslemi-Kebria — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.