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

NCT02778061 | Completed

• 1 other identifier: 15P011
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Intra Uterine Ball; IUD; copper; contraception

Outcome Measures

Primary Outcomes (1)

• Expulsion rate

  1 year

Secondary Outcomes (7)

• Pregnancy rate

  1 year

• Subject satisfaction: will be evaluated on a scale from 1 - 10 in a questionnaire (= case report from)

  1 year

• Change in menstrual pattern before and after insertion of IUB SCu300B device on a scale from 1 - 10 in the questionnaire (= case report form)

  Before and (at least) 1 year after the insertion of IUB SCu300B

• Complication rate including malposition, perforation and infection

  1 year

• Discontinuation rate

  1 year

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants may be included in the study if they are adult nulliparous, uniparous or multiparous females aged 18-42 and had an IUB SCu300B inserted at least 12 month prior to initiation of study data collection.

You may qualify if:

• Adult nulliparous, uniparous or multiparous females age 18 and over.
• Free and willing to give information regarding their experience.
• Given written informed consent.

You may not qualify if:

• Enrollment in or planned to be enrolled in another study.

Sponsors & Collaborators

• Ocon Medical Ltd.: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: May 19, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share