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RecruitingNCT06938750

Novel Medical Device for Pharmacological Therapy

A Pilot Study of a Novel Medical Device for Pharmacological Therapy: The SecHold Device

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
262 (estimated)
Sponsor
Fundacion Miguel Servet · Academic / Other
Sex
All
Age
1 Year
Healthy volunteers
Not accepted

Summary

Background: Different co-creation methods were used to design and prototype a new fixative device for multiple intravenous therapies with the ability to control and identify the pharmacological therapy administered to a patient. Objectives: To validate a newly created device for the reduction of complications related to the use of intravenous therapy Methods: A multidisciplinary team composed of eight professionals specializing in the field of critical care and an engineering professional in industrial design was responsible for collecting, evaluating, and materializing the ideas and needs arising from clinical practice in a device that met the standards of the same.

Conditions

Interventions

TypeNameDescription
DEVICESECHOLD DEVICEPLACEMENT OF A MULTIPLE THERAPY GRIPPING DEVICE TO FIX THE DRIPPER SYSTEMS ALONG ITS PATH TO SOME SURFACE OR SPACE, AVOIDING IT TO REMAIN IN THE AIR, WITHOUT MARKING OR LABELING AND FAVORING ITS ORGANIZATION. SECHOLD is a vascular access fixation device designed for critical clinical environments such as ICU and operating rooms. It allows the simultaneous connection of 3-6 parenteral therapies to the same vascular access, ensuring clear and protocolized identification of each drug by means of labels with name, concentration and infusion range, in addition to a universal color code. This reduces the risk of drug administration errors and facilitates optimal visualization of essential information. SECHOLD also organizes infusion systems connected to the same vascular access, preventing knots and pulls that can compromise catheter integrity in case of accidental infusion bag drops.

Timeline

Start date
2023-01-20
Primary completion
2026-01-31
Completion
2026-09-20
First posted
2025-04-22
Last updated
2025-04-22

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT06938750. Inclusion in this directory is not an endorsement.

Novel Medical Device for Pharmacological Therapy (NCT06938750) · Clinical Trials Directory