NCT07387653 Feasibility and Clinical Utility of Paired Non-Invasive Hemodynamic and Tissue Oximetry Monitoring to Detect Limb Ischemia in Lithotomy-Positioned Surgeries
| NCT ID | NCT07387653 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Neuropathy;Peripheral |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-01-29 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2026-01-29 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The LIMB Study is a prospective, observational pilot study evaluating the feasibility of combined non-invasive hemodynamic and lower-limb tissue oximetry monitoring during prolonged minimally invasive pelvic surgeries performed in lithotomy position. Thirty patients will undergo continuous intraoperative monitoring, with the primary outcome being the frequency and duration of tissue oxygen desaturation events and secondary outcomes examining correlations with postoperative limb pain, sensation, and motor function. The study is non-interventional, poses minimal risk, and aims to generate preliminary data to inform future strategies for early detection and prevention of limb ischemia and well-leg compartment syndrome
Eligibility Criteria
Inclusion Criteria: 1. Adult patients 2. Undergoing minimally invasive pelvic surgery (such as hysterectomy, myomectomy, or endometriosis surgery) 3. Surgery performed in lithotomy position 4. Expected surgical duration \> 2 hours as determined by the primary surgeon Exclusion Criteria: 1. Pregnant patients 2. Procedures expected to last \< 2 hours 3. Open surgical approaches 4. Minor procedures 5. Known allergy or sensitivity to adhesives used for monitoring sensors 6. Vulnerable populations (incarcerated, elderly or pregnant)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07387653 clinical trial?
This trial is open to female participants only, studying Neuropathy;Peripheral. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07387653 currently recruiting?
Yes, NCT07387653 is actively recruiting participants. Contact the research team at randa.j.jalloul@uth.tmc.edu for enrollment information.
Where is the NCT07387653 trial being conducted?
This trial is being conducted at Houston, United States, Houston, United States.
Who is sponsoring the NCT07387653 clinical trial?
NCT07387653 is sponsored by The University of Texas Health Science Center, Houston. The trial plans to enroll 30 participants.