The primary objective of this clinical trial is to evaluate the safety and effectiveness of the AltaSeal® implants to provide bilateral mechanical occlusion of the fallopian tubes resulting prevention of pregnancy.
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoints:
Efficacy:
* Pregnancy rate at 12 months.
* Reliance rate
Safety:
* Percentage of adverse events (minor & major) following the device placement
procedure
* Percentage of adverse events (minor & major) following device wearing.
Secondary outcome
Secondary Endpoints
Efficacy:
* Successful bilateral placement rate
* Patient satisfaction with device placement procedure and wearing
* Data for the development of the clinical patient profile for appropriate use
of the AltaSeal device
Background summary
Background of the study:
Fallopian Tube Sterilisation has been performed for many years using either the
transabdominal or transvaginal/transcervical (hysteroscopic) route. Fallopian
Tube Sterilisation involves disrupting the fallopian tube to ensure that sperm
cannot get access to the egg and therefore allow fertilisation. Blocking the
tubes can be achieved by tying, cutting, sealing, application of clamps, clips
or rings, or removing a section of the fallopian tube.
Currently, tubal ligation requires an abdominal incision and is carried out
under a general or local anaesthetic.
Hysteroscopic sterilisation involves accessing the fallopian tube in a
non-invasive fashion via the uterine cervix, using a hysteroscope.
Hysteroscopic sterilisation has moved female sterilization from a minimally
invasive laparoscopic technique, which requires entry into the abdominal
cavity, to a less invasive hysteroscopic procedure. Along with the decreased
potential for complications, its ease of performance with minimal anaesthesia
has facilitated a move from the operating room to the doctor*s office.
The benefits of hysteroscopic sterilisation include:
* Less invasive * no surgery is required and therefore no laparoscopic risks or
skin incisions.
* Beneficial for patients contraindicated for general anaesthetic such as obese
patients.
* Office-based procedure.
* Rapid recovery time.
* Reduced costs for hospital and patients.
* No surgical incisions required, therefore:
* No risk of bowel injury through adhesions such as patients with previous
surgery or inflammatory bowel disease.
* Less risk of bleeding complications in case of clotting disorders or
anti-coagulant medication
* Risks associated with hormone-based contraceptives eliminated.
While the possibility of carrying out fallopian tube sterilisation with a
hysteroscope had been considered for many years the first product to receive
FDA approval was the Essure® device from Bayer (Conceptus Inc.). The Essure®
implant is made from a 316LVM stainless steel coil, nickel-titanium coil and
polyethylene terephthalate (PET) fibres. The Essure® implant is placed
hysteroscopically and its mechanism of action is the occlusion over many months
as a result of tissue fibrosis around and through the implant to occlude the
fallopian tube. The Essure® device requires the patient to wait a minimum of
three months to ensure tissue fibrosis enables fallopian tube occlusion. The
patient must then
return after three months for a confirmatory HSG (X-ray) to confirm fallopian
tube occlusion.
AltaScience believes that the AltaSeal® device will have the following
potential clinical advantages over the Essure® hysteroscopically placed tubal
occlusion implant:
* Mechanical occlusion resulting in permanent sterilisation.
* Easy to place.
* Minimal user training.
* The AltaSeal® implant is shorter than Essure® and is placed within the
fallopian tube, therefore AltaSeal® will not protrude into the uterine cavity
as Essure® does.
* No intra-abdominal fibrotic reaction (PET fibres in Essure® device can cause
fibrotic reaction in case of unintended perforation).
* AltaSeal® is made from 316LVM Stainless Steel
Study objective
The primary objective of this clinical trial is to evaluate the safety and
effectiveness of the AltaSeal® implants to provide bilateral mechanical
occlusion of the fallopian tubes resulting prevention of pregnancy.
Study design
This study is a multicentre, non-randomised, single arm study of patients
seeking permanent contraception. This study is designed to evaluate the safety
and efficacy of the AltaSeal® device. During the study 180 patients will be
recruited. The study design is set out to investigate each of the stated
objectives above and minimise potential bias. See research protocol (Section
7, Biostatistical Analysis Plan) for details.
Intervention
Hysteroscopic sterilization by mechanical bilateral occlusion of the fallopian
tubes.
Study burden and risks
Risks
The risks and possible adverse events associated with the implant placement
procedure are as follows: Update risks
1) Pregnancy, ectopic pregnancy, and risks associated with the treatment for
both.
2) Incorrect placement of the implant that cannot be relied upon for
contraception and that may result in post-operative pain and require surgical
removal.
3) Placement not possible in either fallopian tube.
4) Implant expulsion (movement into the uterine cavity or out of the body) or
migration (movement to the distal fallopian tube or out of the fallopian tube
into the peritoneal cavity).
5) Abdominal and/or pelvic pain, cramping and vaginal bleeding may occur both
during and after implant placement. This should be mild and treated with
paracetamol.
6) Nausea or vomiting may occur during and/or directly after placement. This is
expected to be transient and successfully treated with medication.
7) Perforation or dissection of the fallopian tube or uterus with possible
injury to the bowel, bladder and major blood vessels.
8) Migraines.
9) Irregular and/or heavier periods.
10) Back Pain.
11) Swelling around the groin region.
12) Infection causing damage to uterus, fallopian tubes or pelvic cavity.
13) Additional risks associated with follow-up procedures.
14) Fainting or vasovagal response.
15) Excessive absorption of distension media.
16) Vaginal bleeding, cramping and bloating from coming off hormonal
contraception.
17) Unknown risks not yet identified.
Following the AltaSeal® procedure the risks and possible adverse events
associated with potential future medical procedures are as follows:
* Unknown risks associated with electrocautery procedures. It is recommended
that electrocautery be avoided in surgical procedures undertaken on the uterine
cornua and fallopian tubes.
* Any intrauterine procedure which could disturb the implants and adversely
affect the ability of the implants to prevent pregnancy.
* Risks not yet identified.
Benefits
The direct benefit to the patient for participating in this study is the
opportunity to select a simple and minimally invasive method of permanent
contraception that can be carried out within a short procedure time.
Additional potential benefits to the patient when compared to the alternative
method of hysteroscopic sterilisation include:
* The ability to achieve permanent contraception using small biocompatible
implants manufactured from 316LVM stainless steel.
* An implant that is easy to place, to deploy, is relatively safe and
potentially is immediately effective.
Additional potential benefits to the patient when compared to existing methods
of sterilisation and contraception are as follows:
* Less invasive * no surgery is required and therefore no laparoscopic risks or
skin incisions.
* Beneficial for patients contraindicated for general anaesthetic such as
obese patients.
* Office-based procedure.
* Rapid recovery time.
* Reduced costs for hospital and patients.
* No surgical incisions required.
* Risks associated with hormone-based contraceptives eliminated.
AltaScience Ltd, 2012 Orchard Anvenue, Citywest Business Campus Trinitas House
Dublin D24
IE
AltaScience Ltd, 2012 Orchard Anvenue, Citywest Business Campus Trinitas House
Dublin D24
IE
Listed location countries
Age
Inclusion criteria
1) Patients aged 22 to 44 years.
2) Body weight within range of 40-180kg.
3) Patients who are seeking permanent contraception.
4) Patients who have at least one live birth.
5) Patients who are willing to participate in a clinical study and are able to
provide written informed consent prior to study participation and agree to
comply with all study specified requirements.
6) Willing to undergo a TV/TA ultrasound both immediately and at 12 weeks
following implantation of the device.
7) Willing to use cover contraception for 3 months post implantation.
8) Patients with a negative urinary hCG test.
Exclusion criteria
1) Patients uncertain about their desire to end fertility.
2) Patients with only one fallopian tube.
3) Patients who are pregnant or suspected pregnant.
4) Patients who have had a delivery or termination of a second trimester
pregnancy less than 6 weeks before the AltaSeal® placement procedure.
5) Patients who have previously undergone a tubal ligation or other permanent
sterilisation methods e.g. Essure® device.
6) Patients with active or recent upper or lower pelvic infection.
7) Patients in whom both tubal ostia cannot be clearly identified .
8) Patients with a bifid uterus which inhibits implant placement.
9) Patients with a known allergy to any of the materials used in the device.
10) Patients with a known allergy to contrast media.
11) Patients undergoing immunosuppressive therapy.
12) Patients who, in the investigator*s opinion, are not suitable candidates
for the device placement procedure due to inability to comply with the protocol
requirements.
13) Patients who are incapable of giving their own consent.
14) Patients with a cervical or uterine malignancy or un-investigated irregular
vaginal bleeding.
15) Patients who are unsuitable for general/local anaesthetic or the sedation
to be used during the procedure.
16) Patients who have a history of severe cramping or abdominal/pelvic pain.
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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 | NL60282.015.16 |