Median Arcuate LigamentNCT07888764
Novel Feasibility Study Demonstrating the Utility of the Intuitive Da Vinci Single Port Robotic System for Treatment of Median Arcuate Ligament Release
An observational study of Median Arcuate Ligament, run by University of Alabama at Birmingham.
Trial summary
This is a prospective, non-randomized, single arm, single center feasibility study to investigate surgical feasibility and technical success of robotic treatment for Median Arcuate Ligament Syndrome using the Intuitive Da Vinci Single Port Robot. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Median Arcuate Ligament
- What is being tested?
- Single Port Robotic Median Arcuate Ligament Release
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2027
- Phase
- Observational
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with median arcuate ligament syndrome.
Who may be able to join
- 1. Adult Patients (older than 22 years of age) 2. Diagnosed with Median Arcuate Ligament Compression Syndrome 3. Indicated for minimally invasive robotic approach as determined by principle investigators.
- 4. Elective Presentation 5. Ability to complete follow-up per protocol.
Who cannot join
- Pediatric patients (<22 years of age)
- Urgent or emergent clinical presentations
- Pregnant females.
- Incarcerated individuals
- Known connective tissue disorders or aortopathies.
- Anatomy not amenable to robotic minimally invasive approach as determined by the principle investigators.
- Expected Survival of less than 5 years due to high-risk comorbidities.
About this study
This is a prospective, non-randomized, single arm, single center feasibility study to investigate surgical feasibility and technical success of robotic treatment for Median Arcuate Ligament Syndrome using the Intuitive Da Vinci Single Port Robot.
This study aims to systematically collect and analyze data on patient demographics, operative details, postoperative complications, length of hospital stay, and overall recovery times following vascular surgery robotic-assisted procedures. By establishing a comprehensive database of outcomes, the study seeks to demonstrate the efficacy and safety of the DaVinci SP system, providing insights that could inform clinical practices and enhance surgical techniques in robotic-assisted laparoscopic surgery.
The purpose of this early feasibility study is to evaluate whether the Da Vinci SP system provides adequate visualization, workspace access, instrument reach, and procedural control to safely perform robotic median arcuate ligament release. The study is not powered to demonstrate superiority over existing surgical approaches.
- Conditions
- Median Arcuate Ligament
- Being tested
- Single Port Robotic Median Arcuate Ligament Release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Port Robotic Median Arcuate Ligament ReleaseProcedure or surgery
Single port robotic median arcuate ligament release is being investigated as an alternative to an open surgical release.
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Feasibility
Successful completion of robotic median arcuate ligament release without conversion to an alternative operative approach.
Technical success is defined as successful completion of all intended procedural steps including:
- Exposure of the supraceliac aorta
- Identification of the median arcuate ligament
- Complete division of the median arcuate ligament
- Division of the celiac plexus fibers
- Absence of major vascular injury
- Absence of unplanned conversion
Technical success differs from conversion rate in that conversion rate measures only procedural completion, while technical success evaluates completion of all intended operative objectives.
Measured: 30-days
Safety
Rate of Clavien-Dindo Grade III or greater adverse events within 30 days.
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Median Arcuate LigamentStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliet Blakeslee-Carter, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888764
- Sponsor's protocol ID
- UABMALS
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No Individual participant data will be shared.