The primary objective of this clinical trial is to evaluate the safety and effectiveness of the AltaSeal® implants in providing bilateral mechanical occlusion of the fallopian tubes and in preventing pregnancy.Additional objectives are as follows:*…
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoints:
Safety is assessed by measuring major complication rates/serious adverse event
rates associated with the use of the AltaSeal® device.
Efficacy is assessed by measuring the number of confirmed pregnancies at 1 year
among patients told to rely on AltaSeal® for contraception.
Secondary outcome
Secondary Endpoints:
The secondary endpoints of this Pivotal Study are minor complications, reliance
rate and patient satisfaction and comfort with placement procedure and device
wearing.
The overall aim of the AltaSeal® device in this study is to achieve bilateral
occlusion of the fallopian tubes in a manner that is tolerable and safe to the
patient. The primary safety and efficacy endpoints will be the principal
indicators of success.
Background summary
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 (Figure 4).
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:
o No risk of bowel injury through adhesions such as patients with
previous surgery or inflammatory bowel disease.
o 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, a 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 * no risk of nickel metal
allergy.
Study objective
The primary objective of this clinical trial is to evaluate the safety and
effectiveness of the AltaSeal® implants in providing bilateral mechanical
occlusion of the fallopian tubes and in preventing pregnancy.
Additional objectives are as follows:
* To determine the ease of inserting the device into the fallopian tube
(investigator feedback);
* To determine the ease of achieving correct placement of the device in the
intramural section of the fallopian tube;
* To determine non-migration of the implant by TV/TA ultrasound;
* To measure the average implantation procedure time;
* To evaluate patient comfort before and after procedure.
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 214 patients will be recruited. The study design is
set out to investigate each of the stated objectives above and minimise
potential bias. In order to do this, it is intended that after screening has
taken place, 214 patients shall partake in the study and shall receive two
AltaSeal® devices (1 in each fallopian tube). If the patient meets the
requirements of the clinical investigation (inclusion/exclusion criteria), they
shall be invited to participate, give consent and shall subsequently be
assigned a patient number.
Intervention
Hysteroscopic sterilization by mechanical bilateral occlusion of the fallopian
tubes.
Study burden and risks
RISKS
The risks and possible side effects associated with the implant placement
procedure are as follows:
* Pregnancy.
* Abdominal/pelvic pain, cramping and vaginal bleeding may occur during and/or
after implant placement. This is usually mild and treated with paracetamol.
* Nausea or vomiting may occur during and/or directly after placement. This is
expected to be transient and successfully treated with medication.
* Fainting or vasovagal response.
* Perforation or dissection of the fallopian tube or uterus with possible
injury to the bowel, bladder and major blood vessels.
* Incorrect placement of the implant that cannot be relied upon for
contraception and that may result in post-operative pain and require surgical
removal.
* Placement not possible in either fallopian tube.
* Excessive absorption of distension media.
* Infection causing damage to uterus, fallopian tubes or pelvic cavity.
* 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).
* Further risks associated with follow-up procedures.
The risks and possible side effects associated with potential future 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 could interrupt the implants and adversely affect
the ability of the implants to prevent pregnancy.
* There is the potential that unknown risks exist.
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 alternative
methods of hysteroscopic sterilisation are as follows:
* The ability to achieve permanent contraception using small implants made
solely from the widely used medical grade metal, 316LVM stainless steel.
* An implant that is easy to place and deploy, is relatively safe and
potentially 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., Trinitas House, 2012 Orchard Avenue, Citwest 2012
Dublin 24
IE
AltaScience Ltd., Trinitas House, 2012 Orchard Avenue, Citwest 2012
Dublin 24
IE
Listed location countries
Age
Inclusion criteria
Patients aged 18 to 44 years.
Body weight within range of 40-136kg.
Patients who are seeking permanent contraception.
Patients who have at least one live birth.
Patients who are willing to participate in the clinical study and are able to provide written informed consent prior to study participation and agree to comply with all study specified requirements.
Willing to undergo a transvaginal and/or transabdominal ultrasound following insertion of the device.
Willing to use cover contraception post implantation.
Patients with a negative urinary hCG test.
Exclusion criteria
Patients uncertain about their desire to end fertility.
Patients in whom only one implant can be placed (including patients with apparent contralateral proximal tubal occlusion and patients with a suspected unicornuate uterus).
Patients who are pregnant or suspected pregnant.
Patients who have had a delivery or termination of a second trimester pregnancy less than 6 weeks before the AltaSeal® placement procedure.
Patients who have previously undergone a tubal ligation.
Patients with active or recent upper or lower pelvic infection.
Patients in whom both tubal ostia cannot be clearly identified .
Patients with a bifid uterus which inhibits implant placement.
Patients with a known allergy to any of the materials used in the device.
Patients with a known allergy to contrast media.
Patients undergoing immunosuppressive therapy are discouraged.
Patients who are incapable of giving their own consent.
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 | NL47804.015.14 |