Robot-Assisted Surgery for Surgical Procedures

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Disqualifiers: BMI > 45, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new robotic device, the da Vinci Single Port Robotic System, for abdominal and pelvic surgeries. The device aims to make these surgeries less invasive by using a single, small incision, potentially reducing pain, complications, and recovery time. Suitable participants are those scheduled for these surgeries who do not have severe breathing problems or a body mass index over 45. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the da Vinci Single Port Robotic System is safe for abdominal and pelvic surgeries?

Research has shown that surgeries using the da Vinci Single Port Robotic System are generally safe and well-tolerated. In South Korea, authorities approved this system for chest surgeries in August 2020, indicating its safety in real-world settings. A review of 55 studies found that surgeries with da Vinci systems resulted in less blood loss and fewer complications compared to traditional methods. Consequently, patients often recover better and face fewer risks during surgery. Overall, the system offers precision and control, helping to reduce surgical side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the da Vinci Single Port Robotic System because it represents a leap forward in surgical precision and minimally invasive techniques. Unlike traditional surgery, which often requires larger incisions and more manual handling, this system uses a single small incision to insert robotic instruments. The da Vinci system allows surgeons to perform complex procedures with enhanced dexterity and control, potentially reducing recovery times and minimizing scarring for patients. This technology offers a level of accuracy and finesse that could improve surgical outcomes significantly compared to conventional methods.

What evidence suggests that the da Vinci Single Port Robotic System is effective for abdominal and pelvic surgeries?

Research shows that the da Vinci Single Port Robotic System, used by participants in this trial, helps surgeons perform complex surgeries through one small incision. This can lead to less pain and faster recovery. A review of 30 studies found that using the da Vinci system for surgeries like hysterectomies resulted in less blood loss and shorter hospital stays. The system lowers the risk of complications and side effects, making surgeries safer and more efficient. Overall, evidence suggests that this robotic system can improve surgical results compared to traditional methods. ^{2 5 6 7 8}

Who Is on the Research Team?

Mehdi Moslemi-Kebria

Principal Investigator

City of Hope Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for robot-assisted abdominal or pelvic surgery and have consented to participate. It's not suitable for individuals with a BMI over 45, those who've had unsuccessful minimally invasive surgeries before, or have conditions that make such surgeries risky like severe lung disorders.

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative

Any patient scheduled to undergo robot-assisted abdominal or pelvic procedures

Exclusion Criteria

Body mass index (BMI) > 45

You have had previous abdominal or pelvic surgery that was not minimally invasive and was unsuccessful.

You have a lung condition called chronic obstructive pulmonary disorder that makes minimally invasive surgery unsafe for you.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Patients undergo surgery using the da Vinci SP1098 robotic system

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• da Vinci Single Port Robotic System

Trial Overview The study is testing the da Vinci SP1098 robotic device in performing less invasive abdominal and pelvic surgeries through a single small incision. The goal is to see if it leads to less pain, fewer complications, and faster recovery compared to traditional methods.

How Is the Trial Designed?

Group I: Device feasibility (da Vinci SP1098 robotic system) Experimental Treatment 1 Intervention

Patients undergo surgery using the da Vinci SP1098 robotic system on study.

da Vinci Single Port Robotic System is already approved in United States, European Union for the following indications:

Approved in United States as da Vinci SP for:

• Urological procedures (e.g., prostatectomies, nephrectomies, cystectomies)
• Transoral otolaryngology procedures (e.g., lateral oropharyngectomy, tongue base resection)

Approved in European Union as da Vinci SP for:

• Not specified in provided sources, but generally used for urological and otolaryngology procedures

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The da Vinci single-port robotic system is the latest technology approved for urological procedures, offering new capabilities for surgeons.

The article discusses common challenges faced during its use at the University of Illinois at Chicago and provides practical solutions to enhance its effectiveness in surgical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Port Robotic Surgery: General Principles and Troubleshooting. Lai, A., Chen, GL., di Meo, NA., et al.[2022]

The da Vinci SP robotic surgical system has been found to be safe and feasible for various urological procedures, according to multiple case series, although high-quality studies are still lacking.

The high cost and learning curve associated with the SP system may limit its adoption in healthcare settings, but advancements from other robotic systems could potentially reduce costs and increase usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single Port Robotic Surgery in Urology. Garbens, A., Morgan, T., Cadeddu, JA.[2022]

The initial experience with the da Vinci Single-Port robotic system for transanal minimally invasive surgery (SP rTAMIS) showed that it is a safe and feasible method for excising rectal neoplasms, with no intraoperative complications reported in two patients.

Both patients successfully underwent full-thickness excisions of rectal lesions without any blood loss, and they were able to resume a liquid diet on the same day of surgery, indicating a quick recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First clinical experience with single-port robotic transanal minimally invasive surgery (SP rTAMIS) for benign rectal neoplasms. Marks, JH., Kunkel, E., Salem, JF., et al.[2021]

The da Vinci single port robotic system has been successfully used for radical robotic-assisted laparoscopic prostatectomy (SP-RALP) in 23 patients, demonstrating its safety and feasibility with no conversions to open surgery.

The procedure had a median operative time of 236 minutes, minimal blood loss of 50 mL, and a short hospital stay of just 1 day, indicating effective outcomes for patients undergoing this innovative surgical technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single port robotic radical prostatectomy with the da Vinci SP platform: a step by step approach. Jones, R., Dobbs, RW., Halgrimson, WR., et al.[2021]

The first successful single-port robotic right colectomy in the USA was performed using the da Vinci SP robot, demonstrating its feasibility and safety with no intraoperative complications and minimal blood loss (100 mL).

The patient had a smooth recovery, tolerating a low-residue diet by postoperative day 1 and being discharged by day 3, indicating that the SP robotic approach may enhance recovery times in colorectal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

rSILS: initial clinical experience with single-port robotic (SPr) right colectomy. Marks, JH., Kunkel, E., Salem, J., et al.[2021]

The da Vinci Single-Port (SP) platform is a new robotic surgical system that allows for major urological operations to be performed through a single incision, demonstrating technical feasibility in initial clinical experiences from December 2018 to April 2019.

While the SP platform shows promise for minimally invasive surgery, further multi-center studies and randomized trials are necessary to fully understand its role and compare its outcomes to traditional multi-port robotic systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-port robotic surgery: the next generation of minimally invasive urology. Dobbs, RW., Halgrimson, WR., Talamini, S., et al.[2021]

The da Vinci SP system allows for successful single-port robotic urologic surgeries in 120 patients, demonstrating its efficacy without the need to convert to other surgical approaches.

The surgeries were performed safely, with only two cases experiencing Clavien-Dindo grade III complications, indicating a low rate of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique and perioperative outcomes of single-port robotic surgery using the da Vinci SP platform in urology. Kim, KH., Ahn, HK., Kim, M., et al.[2022]

The da Vinci SP® surgical system was evaluated in a study involving 50 patients undergoing various colorectal procedures, demonstrating significant reductions in operative time as experience with the system increased, indicating improved efficiency.

The study found that the dVSP system is safe for colorectal surgery, with only six mild adverse events reported and no local recurrences, suggesting it is a promising option for oncological procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-incision robotic colorectal surgery with the da Vinci SP® surgical system: initial results of 50 cases. Kim, HS., Oh, BY., Cheong, C., et al.[2023]

Citations

1. intuitive.com intuitive.com/en-us/products-and-services/da-vinci/sp

Single Port | Da Vinci SP Da Vinci SP is a versatile and high-performance single port robotic surgical system that empowers surgeons to approach their surgical procedures differently.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05672368

The da Vinci Single Port Robotic System for Use in ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11362253/

Da Vinci single-port robotic system current application and ... The da Vinci Single-Port Robot System (DVSP) allows three robotic instruments and an articulated scope to be inserted through a single small incision.

4. imrpress.com imrpress.com/journal/CEOG/50/8/10.31083/j.ceog5008158/htm

Robotic Single-Port da Vinci Surgical System (SP1098) in ... Da Vinci SP1098 surgical system was used to perform single-port robotic surgery in both benign and malignant gynecologic disorders. Pelvic organ ...

5. intuitive.com intuitive.com/en-us/about-us/company/research-outcomes

Da Vinci Research and Outcomes An analysis of 30 studies found that robotic-assisted (RAS) benign hysterectomy using the da Vinci system led to reduced blood loss and shorter hospital stays ...

6. intuitive.com intuitive.com/en-us/products-and-services/da-vinci

Da Vinci Robotic Surgical Systems Built from nearly three decades of experience integrating robotics technology with advanced software, da Vinci systems deliver precision, vision, and control.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9264062/

Initial experience with and surgical outcomes of da Vinci ... The next generation system Model SP1098 was then approved for general thoracic surgery in August 2020 in South Korea. The SPS includes three flexible ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666676624000085

Review Article Current applications of da vinci SP surgical ... Despite these limitations, investigators found that gynecologic surgery with SSdV was safe and feasible. 3. Introduction of single port robotic surgery for ...