MyomaPhase 1/2NCT00562471
Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation
A Phase 1/2 study testing Adhibit Adhesion Prevention Gel in people with Myoma, run by Angiotech Pharmaceuticals at 6 sites in 3 countries.
Trial summary
The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove myomas Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Myoma
- What is being tested?
- Adhibit Adhesion Prevention Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jul 2003to Jan 2005
- Phase
- Phase 1/2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperatively, subjects must have had:
- Been scheduled for myomectomy via laparotomy or laparoscopy.
- Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 6 to 8 weeks following myomectomy.
- Been >=18 years of age.
- Provided voluntary written informed consent.
- Been willing to comply with all aspects of the treatment and evaluation schedule.
- Intra-operatively, subjects must have had:
- Had at least one 2 cm incision length on posterior uterine surface, which may include the fundal surface.
Who cannot join
- Preoperatively, subjects must not have had:
- Been pregnant.
- Had a pelvic malignancy.
- Had acute pelvic inflammatory disease.
- Had an immune compromised condition.
- Been a participant in another clinical research study which the investigator believed could interfere with the purpose of this study.
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- Been given corticosteroids intra-operatively or during the course of the postoperative study follow up.
- Intra-operatively, subjects must not have had:
- Had a pelvic malignancy.
- Had a pelvic or abdominal infection.
- Had acute pelvic inflammatory disease.
- Received any adhesion prevention adjuvants or barriers, or peritoneal instillates containing corticosteroids, NSAIDs, or Dextran.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany4 sites
Klinik für Minimal Invasive Chirurgie
Berlin, 14129
Universitätsklinikum Giessen
Giessen, D-35385
Univ. Clinics of Schleswig-Holstein
Kiel, 24105
Bethesda Krankenhaus Wupperta
Wuppertal, 42109
Netherlands Antilles1 site
St. Elizabeth Hospital
Curaçao
About this study
Official title: A Controlled Randomized Multicenter Study to Assess the Safety and Performance of Adhibit™ Adhesion Prevention Gel in Myomectomy Surgery
The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove myomas
Read the detailed description
Postoperative adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of Adhibit™ Adhesion Prevention Gel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing myomectomy via laparotomy or laparoscopy. Subjects were scheduled to return within 6-8 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postoperative adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring method.
- Conditions
- Myoma
- Being tested
- Adhibit Adhesion Prevention Gel, Standard of Care Comparator
- Keywords
- adhesions, gynecologic surgery, laparoscopy, laparotomy, polyethylene glycol, hydrogel, Adhesions following gynecologic surgery to remove myomas
- Medical subject headings
- Myoma, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhibit Adhesion Prevention GelOther
Also called CoSeal Surgical Sealant; CoSeal Adhesion Prevention Gel
A resorbable hydrogel, which adheres to itself and the tissues it contacts, is approved for use in sealing vascular reconstructions. The hydrogel is formed when two synthetic derivatized polyethylene glycol (PEG) polymers are mixed together and applied to tissue. Using a gas-assisted delivery device, the hydrogel is sprayed over all myomectomy suture lines and all surgically treated areas during the myomectomy surgery. The hydrogel is totally resorbed within 30 days post-application.
Standard of Care ComparatorOther
standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Adhesion Prevention Gel Arm Receives: Other: Adhibit Adhesion Prevention Gel |
| 2 | Other | Standard of Care Comparator Arm (standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure) Receives: Other: Standard of Care Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified American Fertility Society (mAFS) score at the posterior uterus
Measured: 6-8 weeks following primary myomectomy surgery
Secondary outcomes (1)
adhesion extent and tenacity scores at the posterior uterus
Measured: 6-8 weeks following primary myomectomy surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startJul 2003
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyomaStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiotech Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Liselotte METTLE, MD, PhD, Principal investigator, Univ. Clinics of Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562471
- Sponsor's protocol ID
- ADH-02-1
- Other IDs
- ADH-02-1.1, ADH-02-1.2, ADH-02-1.3
- Status last verified
- Nov 2007
- First submitted
- 20 Nov 2007
- Last updated
- 22 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Mettler L, Hucke J, Bojahr B, Tinneberg HR, Leyland N, Avelar R. A safety and efficacy study of a resorbable hydrogel for reduction of post-operative adhesions following myomectomy. Hum Reprod. 2008 May;23(5):1093-100. doi: 10.1093/humrep/den080. Epub 2008 Mar 17.
PubMed 18346996
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Randomized Multicenter Study to Assess the Safety and Performance of Adhibit™ Adhesion Prevention Gel in Myomectomy Surgery
- ClinicalTrials.gov ID
- NCT00562471
- Acronym / sponsor ID
- ADH-02-1
- Conditions
- Myoma
- Keywords
- adhesions, gynecologic surgery, laparoscopy, laparotomy, polyethylene glycol, hydrogel, Adhesions following gynecologic surgery to remove myomas
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Angiotech PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Study completion
- Jan 2005 (actual)
- First posted
- 22 Nov 2007 (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 purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove myomas
Detailed description
Postoperative adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of Adhibit™ Adhesion Prevention Gel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing myomectomy via laparotomy or laparoscopy. Subjects were scheduled to return within 6-8 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postoperative adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Adhibit Adhesion Prevention GelAdhesion Prevention Gel Arm |
| 2 | Other | Other: Standard of Care ComparatorStandard of Care Comparator Arm (standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Been scheduled for myomectomy via laparotomy or laparoscopy.
- Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 6 to 8 weeks following myomectomy.
- Been >=18 years of age.
- Provided voluntary written informed consent.
- Been willing to comply with all aspects of the treatment and evaluation schedule.
Key exclusion criteria (12 listed)
- Been pregnant.
- Had a pelvic malignancy.
- Had acute pelvic inflammatory disease.
- Had an immune compromised condition.
- Been a participant in another clinical research study which the investigator believed could interfere with the purpose of this study.
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 |
|---|---|---|
| Adhibit Adhesion Prevention GelAlso: CoSeal Surgical Sealant; CoSeal Adhesion Prevention GelA resorbable hydrogel, which adheres to itself and the tissues it contacts, is approved for use in sealing vascular reconstructions. The hydrogel is formed when two synthetic derivatized polyethylene glycol (PEG) polymers are mixed together and applied to tissue. Using a gas-assisted delivery device, the hydrogel is sprayed over all myomectomy suture lines and all surgically treated areas during the myomectomy surgery. The hydrogel is totally resorbed within 30 days post-application. | Other | 1 |
| Standard of Care Comparatorstandard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure | Other | 2 |
Primary outcome
modified American Fertility Society (mAFS) score at the posterior uterus
Time frame: 6-8 weeks following primary myomectomy surgery
1 secondary outcome
adhesion extent and tenacity scores at the posterior uterus
Time frame: 6-8 weeks following primary myomectomy surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2007.
- Derived from this study: PubMed 18346996Mettler L, Hucke J, Bojahr B, Tinneberg HR, Leyland N, Avelar R. A safety and efficacy study of a resorbable hydrogel for reduction of post-operative adhesions following myomectomy. Hum Reprod. 2008 May;23(5):1093-100. doi: 10.1093/humrep/den080. Epub 2008 Mar 17.
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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.
Liselotte METTLE, MD, PhD principal investigator
Univ. Clinics of Schleswig-Holstein
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adhibit Adhesion Prevention Gel in people with Myoma, run by Angiotech Pharmaceuticals at 6 sites in 3 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 22 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Canada, Netherlands Antilles. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
modified American Fertility Society (mAFS) score at the posterior uterus (time frame: 6-8 weeks following primary myomectomy surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00562471, which also lists 1 linked publication.
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 22 Nov 2007.