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IUB(TM) SCu300B - Post Marketing Performance Study in Austria

NCT02778061 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2020-09-25

No results posted yet for this study

Summary

Participating investigators will locate all IUB B insertions conducted at their facility at least 12 month prior the initiation of study data collection. The study is composed of 2 parts. Part one is collecting data out of patient's medical record which is accessible only to the doctor. This data is mostly demographic. Part two of the study comprises a phone call to the patients done by the doctor or by authorized site personnel. In the phone call the study purpose will be explained to the patient and a patient consent will be required. After the patients consent to participate, the doctor will ask the patient the questions defined in the study protocol regarding her experience during the time since the IUB SCu300B's insertion.

A total of 200 eligible subjects will be invited to participate in the study. Informed Consent Form will be signed and sent to the investigator, applicable CRFs will be completed by the investigator or authorized site personnel. The patient questionnaires will be asked on the telephone and entered directly into the CRF by the investigator or authorized site staff (CRF = source document). Also the physician´s questionnaire will be directly completed in the CRF by the investigator (CRF = source document). All other clinical data will be transcribed to the CRF from the medical patient records (patient records = source document).

There are no planned patient visits to the doctor's office for study purposes. If the patient visits the physician´s office as part of the clinical routine, the study procedures can also be performed directly at the site instead of telephone contacts.

Conditions

  • Contraception

Sponsors & Collaborators

  • Ocon Medical Ltd.

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-12-31
Completion
2016-12-31

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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 NCT02778061 on ClinicalTrials.gov