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Not yet recruitingNCT07888764Updated Oct 22, 2026

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 in Median Arcuate Ligament, sponsored by University of Alabama at Birmingham. Not yet recruiting. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by University of Alabama at Birmingham · Observational

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5
Ages
22 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Median Arcuate Ligament
03

In context

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,416 studies on the registry; 278 are open to participants now.

Of its 160 completed or terminated interventional studies of FDA-regulated products, 128 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with median arcuate ligament syndrome.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  1. Pediatric patients (\<22 years of age)
  2. Urgent or emergent clinical presentations
  3. Pregnant females.
  4. Incarcerated individuals
  5. Known connective tissue disorders or aortopathies.
  6. Anatomy not amenable to robotic minimally invasive approach as determined by the principle investigators.
  7. Expected Survival of less than 5 years due to high-risk comorbidities.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5 participants (estimated)
Patient registry
No

Interventions

  • ProcedureSingle Port Robotic Median Arcuate Ligament Release

    Single port robotic median arcuate ligament release is being investigated as an alternative to an open surgical release.

06

What researchers measure

Primary outcomes

  1. 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: 1. Exposure of the supraceliac aorta 2. Identification of the median arcuate ligament 3. Complete division of the median arcuate ligament 4. Division of the celiac plexus fibers 5. Absence of major vascular injury 6. 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.

    Time frame: 30-days

  2. Safety

    Rate of Clavien-Dindo Grade III or greater adverse events within 30 days.

    Time frame: 30-days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — No Individual participant data will be shared.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Dec 2027, 11 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2026
First posted
Oct 22, 2026
StartEst.
Jan 1, 2027
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07888764
Responsible party
Juliet Blakeslee-Carter (Assistant Professor of Surgery, University of Alabama at Birmingham) — Principal investigator
First posted
Oct 22, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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