7.1 Primary objectiveThe primary objective of the study is to assess the attitude towards the use of the MedRing 7.2 Secondary objectiveThe secondary objectives of the study are to assess device related adverse events, device damage and physician…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen, hulpmiddel is dummy
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
7.1 Primary objective
The primary objective of the study is to assess the attitude towards the use of
the MedRing
Secondary outcome
7.2 Secondary objective
The secondary objectives of the study are to assess device related adverse
events, device damage and physician satisfaction.
Background summary
Vaginal rings, also called pessaries, are being used for many decades in
gynaecological practice. A wide variety of rings has been used and are still
used for urogenital problems as urinary incontinence. The safety of use of
vaginal rings has been well established. [REF-1]
Pessaries are used for urinary incontinence and pelvic organ prolapse (POP).
These indications are all relatively long-term indications and often require
long-term use of the product. Most intravaginal pessaries are currently
manufactured from medical grade silicone because the material is flexible,
pliable, long-lasting, non-absorbent, biologically inert, non-allergenic,
non-carcinogenic, washable and can generally be sterilized using boiling water.
[REF-2]
The Sponsor, LiGalli, is developing MedRings for vaginal drug delivery and/or
diagnostics. The heart of this device in development is a micronized
electromechanical system. Vaginal drug delivery and body signal registration
offers many advantages. The first intended application of the MedRing is the
vaginal programmed administration of oxybutynin for female patients suffering
from overactive bladder syndrome (OAB). OAB is defined as *urinary urgency,
usually with urinary frequency and nocturia, with or without urgency urinary
incontinence* according to the guidelines of the ICS/IUGA. [REF-3,4]
The current routes of administration of oxybutynin are being accompanied with
frequent and severe side effects. Up to 60% of the users experience
anticholinergic side effects of the oral route medication. The transdermal
route with the use of a oxybutynin patch suffers from skin irritation causing
cessation of the therapy by a high number of users. Side effects cause
withdrawal from treatment with both treatment routes.
Controlled vaginal administration of oxybutynin could have the potential to be
effective at low dose with minimal anticholinergic side effects.
The vaginal route of drug delivery can be typified as a *semi-parenteral* route
and the uptake of medication(s) by the vaginal mucosa is excellent. Direct
action at target, no first-pass via the liver as in gastro-intestinal uptake.
In addition, compounds with a low bioavailability or high first-pass effect in
chronic diseases are well suited for this route of drug delivery.
The vaginal mucosa has proven to be an excellent place for diagnostics, due to
the close vicinity of dense vascularization. Recently, a high accuracy in
detecting various chemical compounds and hormones was found.
The electromechanical nature of the future product makes it *smart* and
provides flexibility in dosage, schedule and timing. The future device can be
wirelessly adjusted and controlled.
Although the use of vaginal rings is well accepted, Ligalli wants to have an
acceptability study done to be well informed about the acceptance of the device
by users on ease of use, comfort of use, adverse effects and willingness to use
a vaginal MedRing for therapeutic or diagnostic purpose. The acceptability
study will be executed with a Dummy MedRing from equal medical grade material
and consistency as the future MedRing for drug delivery or diagnostic body
signals registration. The Dummy MedRing does not contain functional content (no
software and no pharmaceutical ingredient).
Study objective
7.1 Primary objective
The primary objective of the study is to assess the attitude towards the use of
the MedRing
7.2 Secondary objective
The secondary objectives of the study are to assess device related adverse
events, device damage and physician satisfaction.
Study design
8 DESIGN OF THE CLINICAL STUDY
This is a prospective, open label, interventional, monocenter study to assess
user acceptability of the Dummy MedRing. The expected enrolment period will be
2 months. The individual duration of the study for the subjects will be 1 month.
8.1 Study design
Subjects will be selected by the Investigator and asked for participation after
oral and written information on the study in a screening visit (visit 1). If
the subject accepts, a patient informed consent (PIC) form is handed over and a
study visit will be scheduled.
At the next visit (enrolment, visit 2, Day 1) the informed consent form is
signed. After enrolment and instructions, the subject will self-insert the ring
and wear it for one hour within the clinic, then self-remove. The ring will be
cleaned and re-inserted. This ring will be worn for one week and the subject
will visit the clinic again (visit 3) and self-remove again. After examination
and cleaning, the ring will be self-inserted the third time, worn for two weeks
and self-removed at the final visit (visit 4). A telephone contact will take
place a week later for safety follow-up. See Section 8.6 for details per visit.
Data will be collected using questionnaires for subjects and Investigator, and
diaries for subjects.
Intervention
insertion of vaginal ring
Study burden and risks
There are no direct benefits for the subjects.
A risk assessment has been carried out and after risk controlling measures the
residual risk associated to the manufacture and use of this product is low.
After evaluating the severity and occurrence of the residual risks it is
concluded that the overall residual risk level is acceptable. Furthermore,
in-use studies have shown that the product can be inserted, worn, and removed
as intended and no unforeseen risks have come forward.
There is a low risk on side effects like vaginal wall irritation, cramps,
vaginal discharge or vaginal bleeding. As vaginal rings (pessaries) have been
used for decades with a high safety profile and track record, the safety of use
of the MedRing Dummy can be expected as high and acceptable.
Koninginnegracht 33
den haag 2514 AC
NL
Koninginnegracht 33
den haag 2514 AC
NL
Listed location countries
Age
Inclusion criteria
8.4.1 Inclusion criteria
1. Subject is female.
2. Subject is willing and able to give written consent for study participation.
3. Subject is aged >=25 and <=75 years.
4. Use of adequate contraception method (if applicable).
5. Screening on cervical cancer less than 5 years ago with normal result.
Exclusion criteria
1. Pregnancy.
2. Irregular vaginal bleeding.
3. The subject has a history of vaginal surgery.
4. The subject has a clinical relevant genital prolaps (POP-Q stage 2).
5. Known hypersensitivity to device material (polypropylene, styrene triblock
copolymer, parafin oil, glue, primer, coloring agents).
6. The subject has symptomatic vaginal discharge (e.g. with itching or bad
odour).
7. Any current illness that would jeopardize the subject*s health or
interpretation of the results of the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73374.100.20 |