Ovarian CystsPhase 3NCT00865488
Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery
A Phase 3 study testing ADHEXIL in people with Ovarian Cysts and Endometriosis, run by OMRIX Biopharmaceuticals at 5 sites in 5 countries.
Trial summary
The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ovarian Cysts, Endometriosis, Adhesions
- What is being tested?
- ADHEXIL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesin 5 countries
- Study dates
- May 2009to Apr 2010
- Phase
- Phase 3
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 18-45 years at screening.
- Patients undergoing elective laparoscopic surgery involving at least one adnexa.
Who cannot join
- Pregnant (including ectopic pregnancy) or breastfeeding patient.
- Patients with a documented diagnosis of cancer.
- Patients with a lymphatic, hematologic or coagulation disorder.
- Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™.
- Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants.
- Patients who have participated in another clinical study within 30 days of enrolment.
- Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: A Prospective, Controlled, Randomized, Multi-Center, Pivotal Study Evaluating the Safety and Efficacy of AdhexilTM in Prevention And/Or Reduction of Adhesions in Gynecology Surgery
The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.
Read the detailed description
Patients will be divided into two arms: 1) patients who will be treated in accordance with standard of care; 2) patients for which ADHEXIL™ will be applied on one ovary and fallopian tube.
- Conditions
- Ovarian Cysts, Endometriosis, Adhesions
- Being tested
- ADHEXIL
- Medical subject headings
- Ovarian Cysts, Endometriosis, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADHEXILBiological
Adhesions prevention
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | patients who will be treated in accordance with standard of care |
| 2 | Experimental | patients for which Adhexil will be applied to prevent/reduce adhesions Receives: Biological: ADHEXIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesions will be assessed according to incidence, extent and severity.
Measured: 8 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startMay 2009
- Primary completionFeb 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CystsStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OMRIX Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eran Kurman, B.med.Sc, MBA, Study chair, OMRIX Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865488
- Sponsor's protocol ID
- AA-GYN-002
- Status last verified
- Dec 2009
- First submitted
- 18 Mar 2009
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Controlled, Randomized, Multi-Center, Pivotal Study Evaluating the Safety and Efficacy of AdhexilTM in Prevention And/Or Reduction of Adhesions in Gynecology Surgery
- ClinicalTrials.gov ID
- NCT00865488
- Acronym / sponsor ID
- AA-GYN-002
- Conditions
- Ovarian Cysts, Endometriosis, Adhesions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- OMRIX BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 19 Mar 2009 (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.
The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.
Detailed description
Patients will be divided into two arms: 1) patients who will be treated in accordance with standard of care; 2) patients for which ADHEXIL™ will be applied on one ovary and fallopian tube.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –patients who will be treated in accordance with standard of care |
| 2 | Experimental | Biological: ADHEXILpatients for which Adhexil will be applied to prevent/reduce adhesions |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female patients aged 18-45 years at screening.
- Patients undergoing elective laparoscopic surgery involving at least one adnexa.
Key exclusion criteria (7 listed)
- Pregnant (including ectopic pregnancy) or breastfeeding patient.
- Patients with a documented diagnosis of cancer.
- Patients with a lymphatic, hematologic or coagulation disorder.
- Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™.
- Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADHEXILAdhesions prevention | Biological | 2 |
Primary outcome
Adhesions will be assessed according to incidence, extent and severity.
Time frame: 8 weeks post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
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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.
Eran Kurman, B.med.Sc, MBA study chair
OMRIX Biopharmaceuticals
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ADHEXIL in people with Ovarian Cysts and Endometriosis, run by OMRIX Biopharmaceuticals at 5 sites in 5 countries.
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 2 inclusion and 7 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: paused, as of the sponsor's last update on 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Germany, Mexico, Russia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Adhesions will be assessed according to incidence, extent and severity. (time frame: 8 weeks post surgery). 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 23 Dec 2009.