NCT07638384

Brief Summary

Demonstration of soft tissue hypoxia on MRI using external compression and muscle contraction.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
35mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2029

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

2.8 years

First QC Date

June 5, 2026

Last Update Submit

June 5, 2026

Conditions

Muscle Oxygenation

Keywords

musclemagnetic resonance imagingexternal pressuremuscle contraction

Outcome Measures

Primary Outcomes (1)

  • Muscle oxygen level

    Using functional MRI to evaluate effect of muscle compression on muscle oxygen. Demonstrating statistically significant change in muscle oxygen in tissues with application of tissue compression and muscle contraction compared to the same, non-compressed tissues with only muscle contraction

    Day 1, during procedure

Secondary Outcomes (1)

  • Deep tissue oxygen level

    Day 1, during procedure

Study Arms (1)

MRI

EXPERIMENTAL

Participant will undergo a single MRI examination of arm with no contrast.

Other: Compression and Contraction

Interventions

Compression and ContractionOTHER

Standard orthopedic Sarmiento brace/ shell applied to participant's arm. Inside the brace will be a standard blood pressure cuff with a soft foam attached. Pressure will be applied intermittently with blood pressure cuff. Participant will also be asked to lift MRI compatible 10 lb. weight.

MRI

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Alert and oriented.
  • Able to lift 10lbs. and hold for 30 seconds
  • Not claustrophobic.
  • Intact sensation in right upper extremity.

You may not qualify if:

  • Latex allergy or allergy to isopropyl alcohol.
  • Skin injury or decreased sensation on right upper extremity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hess Center

New York, New York, 10029, United States

RECRUITING

Study Officials

  • Yudell Edelstein, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yudell Edelstein, MD

CONTACT

212-244-8864yudell.edelstein@mountsinai.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical associate professor

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 10, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 7, 2029

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

There is no staff available to manage data sharing

Locations

US(1)