Disease or DisorderPhase 2NCT05672368
The da Vinci Single Port Robotic System for Use in Abdominal and Pelvic Surgical Procedures
A Phase 2 study testing Robot-Assisted Surgery in people with Disease or Disorder, run by City of Hope Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disease or Disorder
- What is being tested?
- Robot-Assisted Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2024to 21 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Mehdi Moslemi-kebria, 909-949-2242, mkebria@COH.org
Mehdi Moslemi-kebria
About this study
Official title: Phase II Study of the Da Vinci Single Port (SP) Robotic System for Abdominal and Pelvic Procedures
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Disease or Disorder
- Being tested
- Robot-Assisted Surgery
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted SurgeryDevice
Also called Navigation and Robotics, Robot Assisted, Robotic Surgery
Undergo surgery using the da Vinci SP device
| Study group | Role | What they receive |
|---|---|---|
| Device feasibility (da Vinci SP1098 robotic system) | Experimental | Patients undergo surgery using the da Vinci SP1098 robotic system on study. Receives: Device: Robot-Assisted Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion of operation to laparotomy
The number and frequency will be reported with 95% confidence intervals.
Measured: Within 30 days of operation
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.
Measured: Within 30 days of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start26 Apr 2024
- Primary completion21 Sep 2027 (estimated)
- Study completion21 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease or DisorderStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mehdi Moslemi-Kebria, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672368
- Sponsor's protocol ID
- 22446
- Other IDs
- NCI-2022-10346, 22446, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 3 Jan 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Da Vinci Single Port (SP) Robotic System for Abdominal and Pelvic Procedures
- ClinicalTrials.gov ID
- NCT05672368
- Acronym / sponsor ID
- 22446
- Conditions
- Disease or Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 21 Sep 2027 (estimated)
- Study completion
- 21 Sep 2027 (estimated)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device feasibility (da Vinci SP1098 robotic system) | Experimental | Device: Robot-Assisted SurgeryPatients undergo surgery using the da Vinci SP1098 robotic system on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-Assisted SurgeryAlso: Navigation and Robotics, Robot Assisted, Robotic SurgeryUndergo surgery using the da Vinci SP device | Device | Device feasibility (da Vinci SP1098 robotic system) |
Primary outcome
Conversion of operation to laparotomy
Time frame: Within 30 days of operation
The number and frequency will be reported with 95% confidence intervals.
Incidence of major surgical complications
Time frame: Within 30 days of operation
Will be assessed by Clavien-Dindo classification as grade 3 or higher. The number and frequency will be reported with 95% confidence intervals.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mehdi Moslemi-Kebria principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Robot-Assisted Surgery in people with Disease or Disorder, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion of operation to laparotomy (time frame: Within 30 days of operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.