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NCT03330925

Safety and Feasibility of the ElastiMed's SACS

Completed NA Last updated 6 June 2019
What this trial tests

NA trial testing ElastiMed's SACS in Compression; Vein in 11 participants. Completed in 3 December 2018.

Timeline
24 January 2018
Primary endpoint
3 December 2018
3 December 2018

Quick facts

Lead sponsorElastiMed ltd
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposedevice feasibility
Enrollment11
Start date24 January 2018
Primary completion3 December 2018
Estimated completion3 December 2018
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

ElastiMed ltd

Who can join

Adults 18 to 70, any sex, with Compression; Vein. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main objective of this study is to demonstrate the safety and the feasibility of this device, and its ability to increase venous blood flow Primary safety Endpoint: To demonstrate the safety of the device- no serious adverse effect Primary feasibility Endpoint: Increase the blood flow velocity The blood flow will be detected by a Duplex Ultrasonography test at the popliteal vein and the femoral vein. The volunteers will rest at controlled environment room . Measurements will be performed after 30 min of rest without the device on the leg (baseline) and after 30 min of device activity .

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03330925.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing