Pediatric Robotic SurgeryNCT04899557
Retrospective/Prospective Study of Pediatric Surgical Patients
An observational study of Pediatric Robotic Surgery, run by University of Illinois Chicago at 1 site in United States.
Trial summary
UIC Division of pediatric surgery has IRB approval to perform retrospective and prospective study of their pediatric surgical patients. At UIC Dr. Lobe performed the first known single port robotic splenectomy on a child and as a surgical first this case is worthy of a case report. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Pediatric Robotic Surgery
- What is being tested?
- Single Port Robotic Splenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 to 18 years
- All sexes
- Child, Adult
Study population: pediatric patient with splenomegaly
Who may be able to join
- Pediatric patient with splenomegaly
Who cannot join
- NOn pediatric patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Office for the Protection of Research Subjects
Chicago, Illinois, 60612
About this study
UIC Division of pediatric surgery has IRB approval to perform retrospective and prospective study of their pediatric surgical patients. At UIC Dr. Lobe performed the first known single port robotic splenectomy on a child and as a surgical first this case is worthy of a case report. Since it is a surgical and therapeutic first it needs to be aon regestiry of health research prior to publication.
- Conditions
- Pediatric Robotic Surgery
- Being tested
- Single Port Robotic Splenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Port Robotic SplenectomyProcedure or surgery
Pediatric patient with splenomegaly underwent a single port robotic splenectomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Did the patient die from the operation
Measured: 30 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start27 Apr 2021
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Robotic SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greg Klazura, University of Illinois Chicago
- Investigators
- Greg Klazura, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899557
- Sponsor's protocol ID
- 2014-0396
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective/Prospective Study of Pediatric Surgical Patients
- ClinicalTrials.gov ID
- NCT04899557
- Acronym / sponsor ID
- 2014-0396
- Conditions
- Pediatric Robotic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 24 May 2021 (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.
UIC Division of pediatric surgery has IRB approval to perform retrospective and prospective study of their pediatric surgical patients. At UIC Dr. Lobe performed the first known single port robotic splenectomy on a child and as a surgical first this case is worthy of a case report. Since it is a surgical and therapeutic first it needs to be aon regestiry of health research prior to publication.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- pediatric patient with splenomegaly
Key inclusion criteria (1 listed)
- Pediatric patient with splenomegaly
Key exclusion criteria (1 listed)
- NOn pediatric patients
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 |
|---|---|---|
| Single Port Robotic SplenectomyPediatric patient with splenomegaly underwent a single port robotic splenectomy. | Procedure or surgery | – |
Primary outcome
Mortality
Time frame: 30 days post op
Did the patient die from the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
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Advanced SPinal Innovations With Robotics and Enabling Technology Registry
Spine Deformity, Idiopathic Scoliosis
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Stanford Program to Accelerate Robotic Children's Surgery
Sleeve Gastrectomy, Cholecystectomy
Not yet recruitingObservational study
Outcomes of Pediatric Robotic Surgery at a Tertiary Children's Hospital
Robotic Surgical Procedures
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. This study is not recruiting at the moment.
Greg Klazura principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Robotic Surgery, run by University of Illinois Chicago 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Mar 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days post op). 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 3 Mar 2022.