ContraceptionNCT02778061
IUB(TM) SCu300B - Post Marketing Performance Study in Austria
An observational study of Contraception, run by Ocon Medical Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Adult nulliparous, uniparous or multiparous females age 18 and over.
- Free and willing to give information regarding their experience.
- Given written informed consent.
Who cannot join
- Enrollment in or planned to be enrolled in another study.
About this study
Official title: A Retrospective, Post-marketing Study of the Expulsion Rate, Efficacy and Satisfaction From Use of the IUB(TM) SCu300B MIDI Spherical Copper Intrauterine Device in Austria
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.
Read the detailed description
STUDY RATIONALE
IUDs pose several complications to users, such as perforation during insertion, migration and expulsion. IUDs may also cause menorrhagia, discomfort and pain presumably due to distortion of the uterus by their semi-rigid polymeric frame.
A proof of concept study was concluded on the SCu300A (the first approved variant of the IUB™ product family) and published and a comparative study for the SCu300A is ongoing. The purpose of this current study is to obtain performance data on the SCu300B which is CE approved and commercially sold. Since the IUB B has a slightly larger diameter and stiffer frame than the SCu300A - to see if these parameters affect expulsion rate, efficacy and QOL.
This post marketing study aims to verify the IUB™'s SCu300B efficacy. Endpoints include 1 year Expulsion rate, as well as assessment of pregnancy rates, mal-position, perforation, discontinuation rates and physician and participant's satisfaction. These results will be used and will also help in reaffirming the assumption that the IUB™'s design contributes to lower complication and side effect rates.
RISK/BENEFIT ASSESSMENT
Clinical Benefits or risks:
Since this is a retrospective data collection, there will be no risks or benefits for participants. The participants will have a phone call to propose the opportunity to be part of the study. After full explanation of the study aims the patients willing to participate will either consent by phone or sign and e mail a written informed consent form.
RECRUITMENT PLAN
Patients will be recruited to this study by the Ob\Gyn physicians participating in the study. The doctors will address their medical files to allocate patient who has been inserted with an IUB B at least 12 month before data collection begins. At first - only contact information will be found and no other clinical data will be taken out of patient's files.
A phone call to the patient will be done in which the patient will generally be asked if she is willing to participate in a retrospective study. If the patient is willing, the informed consent form will be sent to the patient together with an explanation letter and a pre-addressed envelope per regular mail. If the patient is willing to participate and has sent back the signed informed consent form, the investigator or authorized site staff will call the patient, educate the patient about the research proposal on the phone and ask if there are any questions to be addressed. After all questions are answered the doctor will countersign the ICF.
In the same phone call the patient will be asked the protocol defined questions regarding the past year of IUB use.
STUDY OBJECTIVES
The objective of the proposed study is to evaluate the performance of the IUB™ SCu300B device in clinical use. In particular, the study will:
- Evaluate the safety and performance of the IUB™ by means of objective clinical measures and in particular 1 year expulsion rates, perforation and pregnancy rates.
- Evaluate the usability and patient satisfaction of the IUB™ in terms of physician as well as patient satisfaction for ease of insertion and subject QOL report questions.
- Conditions
- Contraception
- Keywords
- Intra Uterine Ball, IUD, copper, contraception
What is being measured
The primary outcome is the main question the study is designed to answer.
Expulsion rate
Measured: 1 year
Secondary outcomes (7)
Pregnancy rate
Measured: 1 year
Subject satisfaction: will be evaluated on a scale from 1 - 10 in a questionnaire (= case report from)
Subject satisfaction will be evaluated by the subject on a scale from 1 - 10, where 1 is very disappointed, 5 is okay and 10 is very satisfied in the questionnaire (=case report form) filled by the physician (together with subject).
Measured: 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)
The changes in menstrual pattern before and after insertion of IUB SCu300B will be evaluated by the subject on a scale from 1 - 10, where 1 is better, 5 is no change and 10 is worse in the questionnaire (=case report form), filled by the physician together with the subject.
Measured: Before and (at least) 1 year after the insertion of IUB SCu300B
Complication rate including malposition, perforation and infection
Measured: 1 year
Discontinuation rate
Measured: 1 year
Adverse events (AE)
Measured: 1 year
Physician´s assessment on "ease of use" of IUB SCu300B: evaluated by the physician on a scale from 1-10 in the questionnaire (= case report form)
Physician will evaluate the "ease of use" of IUB SCu300B on a scale from 1 - 10, were 1 is very easy to 10 very difficult in the questionnaire (= case report form) filled by the physician.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocon Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778061
- Sponsor's protocol ID
- 15P011
- Status last verified
- Sep 2020
- First submitted
- 13 Apr 2016
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Post-marketing Study of the Expulsion Rate, Efficacy and Satisfaction From Use of the IUB(TM) SCu300B MIDI Spherical Copper Intrauterine Device in Austria
- ClinicalTrials.gov ID
- NCT02778061
- Acronym / sponsor ID
- 15P011
- Conditions
- Contraception
- Keywords
- Intra Uterine Ball, IUD, copper, contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ocon Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
STUDY RATIONALE
IUDs pose several complications to users, such as perforation during insertion, migration and expulsion. IUDs may also cause menorrhagia, discomfort and pain presumably due to distortion of the uterus by their semi-rigid polymeric frame.
A proof of concept study was concluded on the SCu300A (the first approved variant of the IUB™ product family) and published and a comparative study for the SCu300A is ongoing. The purpose of this current study is to obtain performance data on the SCu300B which is CE approved and commercially sold. Since the IUB B has a slightly larger diameter and stiffer frame than the SCu300A - to see if these parameters affect expulsion rate, efficacy and QOL.
This post marketing study aims to verify the IUB™'s SCu300B efficacy. Endpoints include 1 year Expulsion rate, as well as assessment of pregnancy rates, mal-position, perforation, discontinuation rates and physician and participant's satisfaction. These results will be used and will also help in reaffirming the assumption that the IUB™'s design contributes to lower complication and side effect rates.
RISK/BENEFIT ASSESSMENT
Clinical Benefits or risks:
Since this is a retrospective data collection, there will be no risks or benefits for participants. The participants will have a phone call to propose the opportunity to be part of the study. After full explanation of the study aims the patients willing to participate will either consent by phone or sign and e mail a written informed consent form.
RECRUITMENT PLAN
Patients will be recruited to this study by the Ob\Gyn physicians participating in the study. The doctors will address their medical files to allocate patient who has been inserted with an IUB B at least 12 month before data collection begins. At first - only contact information will be found and no other clinical data will be taken out of patient's files.
A phone call to the patient will be done in which the patient will generally be asked if she is willing to participate in a retrospective study. If the patient is willing, the informed consent form will be sent to the patient together with an explanation letter and a pre-addressed envelope per regular mail. If the patient is willing to participate and has sent back the signed informed consent form, the investigator or authorized site staff will call the patient, educate the patient about the research proposal on the phone and ask if there are any questions to be addressed. After all questions are answered the doctor will countersign the ICF.
In the same phone call the patient will be asked the protocol defined questions regarding the past year of IUB use.
STUDY OBJECTIVES
The objective of the proposed study is to evaluate the performance of the IUB™ SCu300B device in clinical use. In particular, the study will:
- Evaluate the safety and performance of the IUB™ by means of objective clinical measures and in particular 1 year expulsion rates, perforation and pregnancy rates.
- Evaluate the usability and patient satisfaction of the IUB™ in terms of physician as well as patient satisfaction for ease of insertion and subject QOL report questions.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Adult nulliparous, uniparous or multiparous females age 18 and over.
- Free and willing to give information regarding their experience.
- Given written informed consent.
Key exclusion criteria (1 listed)
- Enrollment in or planned to be enrolled in another study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expulsion rate
Time frame: 1 year
7 secondary outcomes
Pregnancy rate
Time frame: 1 year
Subject satisfaction: will be evaluated on a scale from 1 - 10 in a questionnaire (= case report from)
Time frame: 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)
Time frame: Before and (at least) 1 year after the insertion of IUB SCu300B
Complication rate including malposition, perforation and infection
Time frame: 1 year
Discontinuation rate
Time frame: 1 year
Adverse events (AE)
Time frame: 1 year
Physician´s assessment on "ease of use" of IUB SCu300B: evaluated by the physician on a scale from 1-10 in the questionnaire (= case report form)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Ocon Medical Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expulsion rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.