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Study on Adhesion Properties of Three Different Adhesives

NCT04125797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2019-11-19

No results posted yet for this study

Summary

This clinical investigation is a single centre, double blinded, case control study in healthy adult females. This study will be conducted in private rooms at Gentofte Hospital (Hjerte-medicinsk Forskning, post 835, Kildegårdsvej 28, 2900 Hellerup).

The investigation centre will enroll 39 subjects including a 20% drop out within a four (4) months period. The subject will not be enrolled before approval of investigation protocol by the local ethics committee.

The subjects need to meet the inclusion and exclusion criteria to be included in this clinical investigation. Each volunteer enrolled in the investigation can only participate once in a procedure. The testing period for each subject will be minimum 72 hours.

The principal investigator's qualifications will be verified through his/her CV. The principal investigator is required to be a medical doctor with at least one year's experience in using similar medical adhesives (e.g. by being experienced in using electrodes where medical adhesives are included) and at least one year's experience with clinical research. In addition, the investigator must be trained in GCP before the study is initiated.

If any subject withdraws from the study, they will not be replaced as drop-out rate is included in the sample size.

Subjects must show up for two sessions, in the first session six adhesives will be placed below the subjects bra. The adhesives will be removed after minimum 72 hours at the second visit. While wearing the adhesives the subjects must keep the investigational area dry. 24, 48 and 72 hours after placement of the adhesives, the subject is asked to completed a questionnaire.

The eCRF must be completed for each subject that has signed the Informed consent form (ICF) and enrolled into this clinical investigation.

Conditions

  • Healthy

Interventions

OTHER

Application of adhesive

Adhesive will be placed on the subjects skin below the bra. Placement of the adhesive will be randomized.

Sponsors & Collaborators

  • Ambu A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04125797 on ClinicalTrials.gov