None listed
Conditions
Brief summary
This is a prospective four-week study of healthy volunteers who will have a new inert drug delivery device affixed to the uterine cervix (without therapeutic drug). To determine 1) Adverse effects of the device for up to four weeks. 2) The suitability of the device remaining in position for up to four weeks.
Interventions
This is a prospective, four-week, single group study of healthy volunteers who will have the new drug delivery device affixed to the uterine cervix (without therapeutic drug). This study is interventional in that this device would otherwise not be used but does not involve a treatment drug. The device will be administered by a gynecologist and be affixed to the cervix by three pins made by digital light processing 3D printing using FDA approved medical device materials. The sterilized device is
This is a prospective, four-week, single group study of healthy volunteers who will have the new drug delivery device affixed to the uterine cervix (without therapeutic drug). This study is interventional in that this device would otherwise not be used but does not involve a treatment drug. The device will be administered by a gynecologist and be affixed to the cervix by three pins made by digital light processing 3D printing using FDA approved medical device materials. The sterilized device is a 2cm x 1cm x 0.5cm triangular patch equipped with shallow pins (5 mm in length) shaped to be affixed to approximately a quarter turn of the cervix for up to 4 weeks. The device will be inserted by O&G specialist with no anesthetic or sedation. Participants will be asked to stay at the hospital for approximately 20 minutes following device fixation to ensure comfort. The device will be removed 4 weeks or at next menstruation, Adverse events and retention observations will be recorded by study personnel at scheduled weekly phone calls/visits, and by participants daily in a diary. Participants will be asked if they would have preferred local anesthetic for the patch application if they were to undergo the procedure again.
Sponsors
Research & Enterprise, University of Otago
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
• Participant is willing and able to give informed consent for participation in the study. • A person with a uterine cervix aged 18 years or above. • Diagnosed with no abnormalities of the cervix that would hinder the insertion of the device. • Stable dose of any current regular medications for at least 4 weeks prior to study entry. • As a healthy volunteer no new medications, whether prescribed or over-the-counter, in the week before device insertion and no individual doses in the final two weeks other than mild analgesia, vitamins and mineral supplements or oral contraceptives. • Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception during the study. • Able (in the Investigators opinion) and willing to comply with all study requirements. • Willing to allow her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion criteria
The participant may not enter the study if ANY of the following apply: • Female participants who is pregnant, lactating or planning pregnancy during the study. • Scheduled elective surgery or other procedures requiring general anaesthesia during the study. • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. • Participants who have participated in another research study involving an investigational product in the past 12 weeks.
Outcome results
None listed