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RecruitingNCT06123104Updated Mar 15, 2024

Assessment of Automatic Tourniquets for Soldiers During Wartime

An interventional study of Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS) in Trauma Injury and Hemorrhage Wound, sponsored by Medical Corps, Israel Defense Force. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Medical Corps, Israel Defense Force · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The goal of this clinical trial is to compare usability and performance of automatic tourniquets (AUT) and standard mechanical tourniquets (CAT) in healthy adults. The main questions it aims to answer are:

  • Are AUTs effective in occlusion of blood flow
  • Are AUTs easy to use

Participants will be asked to place AUT and CAT on their upper limbs and lower limbs (8 applications overall).

Following each application, the following parameters will be assessed:

  1. Limb blood flow
  2. Ease of use

Researchers will compare the results of the AUT and CAT to see if AUT is as effective as CAT in blood occlusion, and if AUT is easy to use as the CAT.

Read the detailed description

The goal of this clinical trial is to compare usability and performance of automatic tourniquets (AUT) and standard mechanical tourniquets (CAT) in healthy adults. The main questions it aims to answer are:

  • Are AUTs effective in occlusion of blood flow
  • Are AUTs easy to use

Participants will be asked to place AUT and CAT on their upper limbs and lower limbs (8 applications overall).

02

Conditions studied

  • Trauma Injury
  • Hemorrhage Wound

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03

In context

Accidental Injuries

128 studies on the registry are indexed under Accidental Injuries; 39 are open to participants now.

This study's planned enrollment of 10 is below the median of 110 across 67 interventional studies indexed under Accidental Injuries.

Browse Accidental Injuries studies →

Lead sponsor

Medical Corps, Israel Defense Force is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

-Soldier in active service or active reserve service.

Exclusion criteria

Exclusion Criteria:

  • Muscle disorders
  • Peripheral nerve disorders
  • Skin diseases of the limbs
  • Limb surgery in the past
  • Rickets
  • Hypertension
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Automatic Tourniquet

    Automatic pneumatic tourniquet

    Device: Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)

  • Active comparator
    Combat Application Tourniquet (CAT)

    Combat Application Tourniquet Generation 7

    Device: Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)

Interventions

  • DeviceOcclusion of blood flow diagnosed by Point of Care UltraSound (POCUS)

    Tourniquets will be applied until peripheral blood flow occlusion is achieved. Total intervention time: up to 60 seconds

06

What researchers measure

Primary outcomes

  1. Time to distal limb arterial occlusion as assessed by Doppler

    Time to distal limb arterial occlusion as assessed by Doppler is recorded

    Time frame: 60 seconds

Secondary outcomes

  1. Safety of using automatic tourniquets

    Safety issues, specifically peripheral limb numbness will be assessed via questionnaire. Scale is from 0 to 5, 0 is "No numbness", 5 is "Severe numbness"

    Time frame: Will be assessed via questionnaire up to 5 minutes following the intervention.

  2. Usability of using automatic tourniquets

    Usability of using automatic tourniquets will be assessed via questionnaire up to 5 minutes following the intervention. Scale for ease to secure the tourniquet is from 0 to 5, 0 is "Very difficult to secure", 5 is "Very easy to secure"

    Time frame: Ease of use will be assessed via questionnaire up to 5 minutes following the intervention.

07

Study locations

1 of 1 sites recruiting
  • Tel hashomer
    Ramat Gan, Israel
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06123104
Lead sponsor
Medical Corps, Israel Defense Force
Responsible party
TOMER ERLICH (Head of Innovation, R&D Directorate, IDF Medical Corps Head of Medical Research, Directorate of Defense R&D, Israeli Ministry of Defense (IMOD DDR&D), Medical Corps, Israel Defense Force) — Principal investigator
First posted
Nov 8, 2023
Start date
Oct 27, 2023
Primary completion
Nov 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Mar 15, 2024

Study contacts

Tomer Erlich, MD
Contact
tomer.erlich@gmail.com
+972-3-737-9506
Tomer Erlich, MD
principal investigator · Head of Medical innovation and R&D

Oversight

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

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