Uterine FibroidsPhase 4NCT01388907
Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery
A Phase 4 study testing Ringer lactate solution and Prevadh film in people with Uterine Fibroids and Fertility Disorders, run by Medtronic - MITG at 11 sites in France.
Trial summary
The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the prevention of adhesions in gynaecologic surgery, and to assess post-operative complications related to adhesions and pregnancy rate after myomectomy by open surgery. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Uterine Fibroids, Fertility Disorders
- What is being tested?
- Ringer lactate solution and Prevadh film
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 11 sitesFrance
- Study dates
- May 2006to Jun 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Symptomatic(s) or asymptomatic(s) uterin(s) fibroma(s) being able to interfere with the fertility by the patient who having an immediate or differed desire of pregnancy.
- Size: diameter ≥ 6 cm at echographia (for the highest diameter)
- Location interstitial and / or subserosa
- planned laparotomic surgery
- negative pregnancy test within 48 hours of surgery
- signed inform consent
Who cannot join
- History of abdomino-pelvic surgery (except appendicectomy - cesarotomy)
- Pre-operative embolization
- Endometriosis stage >1 (American Fertility Society classification ≥ 5)
- Pregnant patient
- Diabetes
- Chronic corticotherapy / immuno-supressor or immuno-modulator drugs
- Previous analog LH-RH drug therapy for the uterine myoma
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
University Hospital
Angers, 49933
Clinique du Tondu
Bordeaux, 33000
Béclère Hospital (Public Assistance of Paris Hospital)
Clamart, 92141
UNIVERSITY HOSPITAL Estaing
Clermont-Ferrand, 63003
University Carémeau Hospital
Nîmes, 30029
TENON Hospital (Public Assistance of Paris Hospital)
Paris, 75020
TROUSSEAU Hospital (Public Assistance of Paris Hospital)
Paris, 75571
Bichat Hospital - Claude Bernard (Public Assistance of Paris Hospital)
Paris, 75877
South University Hospital
Rennes, 35023
Centre Hospitalier des quatre villes
Sèvres, 92317
Versailles Hospital
Versailles, 78157
About this study
Official title: Efficacy and Safety of Prevadh™ in the Prevention of Adhesions in Gynaecological Surgery: a Multicenter, Randomized, French Study
The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the prevention of adhesions in gynaecologic surgery, and to assess post-operative complications related to adhesions and pregnancy rate after myomectomy by open surgery.
Read the detailed description
This study was addressed to patients having an immediate or differed pregnancy desire and presenting a symptomatic or asymptomatic fibroma being able to interfere with fertility.
- The primary end point was the assessment of adhesion rate to the uterine surgical sites during a laparoscopic second look performed 10 to 20 weeks post-surgery.
- The secondary end points were the assessment, throughout a 3 years follow-up period, of:
- pregnancy rate,
- adverse events related to adhesions,
- adnexal adhesions according to American Fertility Society score,
- abdomino-pelvic adhesions according to the modified American Fertility Society score.
- Conditions
- Uterine Fibroids, Fertility Disorders
- Being tested
- Ringer lactate solution, Prevadh film
- Keywords
- myomectomy, adhesion prevention, pregnancy rate
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer lactate solutionOther
Also called Myomectomy by Laparotomy
Ringer lactate solution was applied directly onto the uterine surgical sites at the end of the myomectomy surgery, to prevent post-surgical adhesion formation.
Prevadh filmDevice
Also called Myomectomy by Laparotomy
Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.
| Study group | Role | What they receive |
|---|---|---|
| Prevadh film | Experimental | Patient randomized in this arm have been treated with Prevadh film applied on the uterine surgical sites, at the end of the myomectomy surgery to prevent post-surgey adhesion formation. Receives: Device: Prevadh film |
| Ringer solution | Active comparator | Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery. Receives: Other: Ringer lactate solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adhesions to Uterine Scars
The primary endpoint was the assessment of adhesions to uterine scars and comprised the incidence (expressed per patient and per uterine scar), extent, and severity of adhesions observed during the second-look laparoscopy performed 10 to 20 weeks after the myomectomy.
This assessment was made by the surgeon (investigator) on the one hand and by two independent surgeons who reviewed the video recordings on the other hand.
Measured: 10 to 20 weeks post surgery
Secondary outcomes (3)
Fertility
Fertility was assessed by pregnancy and deliveries rates at 3 years.
Measured: 3 years
Adnexal Adhesions
Adnexal Adhesions were assessed by AFS score. AFS (= American Fertility Society) score was developed in 1980's by the American Fertility Society in an effort to address needs for a classification scheme for adnexal adhesions suspected to be associated with infertility. 4 anatomic sites evaluated: R-tube; R-ovary; L-tube; L-ovary. Final AFS score for a patient is the score of the side with lower summed score. The higher score, representing the side with the higher adhesion burden, is dropped; Score AFS is from 0 (best possible outcome) to 32 (worse possible outcome).
Measured: 10 to 20 weeks post surgery
mAFS Abdominopelvic Adhesion Score
mAFS abdominopelvic adhesion score in 23 sites (at the anterior caudal peritoneum; parietocolic gutter right; right and left colon; right and left anterior cranial peritoneum; rectosigmoid; omentum; small intestine; anterior and posterior uterus; posterior cul-de-sac; right and left ovaries [internal and lateral sides], pelvic side walls, ovarian fossae, tubes, and bulbs). It ranges from 0 (best possible outcome) to 16 (worse possible outcome).
Measured: 10 to 20 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 posted7 Jul 2011 (estimated)
- Study startMay 2006
- Primary completionJun 2008
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Responsible party
- Sponsor
- Investigators
- BECKER Patrice, Study director, Sofradim ProductionCANIS Michel, Pr, Principal investigator, University Hospital Estaing - 63003 CLERMONT-FERRAND Cedex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388907
- Sponsor's protocol ID
- CLI 9821-2
- Status last verified
- Nov 2016
- First submitted
- 5 Jul 2011
- Last updated
- 17 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Canis MJ, Triopon G, Darai E, Madelenat P, LeVeque J, Panel P, Fernandez H, Audebert A, Descamps P, Castaing N, Roman H, Fauconnier A, Benifla JL. Adhesion prevention after myomectomy by laparotomy: a prospective multicenter comparative randomized single-blind study with second-look laparoscopy to assess the effectiveness of PREVADH. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:42-7. doi: 10.1016/j.ejogrb.2014.03.020. Epub 2014 Apr 8.
PubMed 24841647
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Prevadh™ in the Prevention of Adhesions in Gynaecological Surgery: a Multicenter, Randomized, French Study
- ClinicalTrials.gov ID
- NCT01388907
- Acronym / sponsor ID
- CLI 9821-2
- Conditions
- Uterine Fibroids, Fertility Disorders
- Keywords
- myomectomy, adhesion prevention, pregnancy rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Study start
- May 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Jul 2011 (estimated)
- Results
- Posted 17 Nov 2016
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 evaluate clinically the efficacy of the PREVADH® Film in the prevention of adhesions in gynaecologic surgery, and to assess post-operative complications related to adhesions and pregnancy rate after myomectomy by open surgery.
Detailed description
This study was addressed to patients having an immediate or differed pregnancy desire and presenting a symptomatic or asymptomatic fibroma being able to interfere with fertility.
- The primary end point was the assessment of adhesion rate to the uterine surgical sites during a laparoscopic second look performed 10 to 20 weeks post-surgery.
- The secondary end points were the assessment, throughout a 3 years follow-up period, of:
- pregnancy rate,
- adverse events related to adhesions,
- adnexal adhesions according to American Fertility Society score,
- abdomino-pelvic adhesions according to the modified American Fertility Society score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevadh film | Experimental | Device: Prevadh filmPatient randomized in this arm have been treated with Prevadh film applied on the uterine surgical sites, at the end of the myomectomy surgery to prevent post-surgey adhesion formation. |
| Ringer solution | Active comparator | Other: Ringer lactate solutionPatients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery. |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Symptomatic(s) or asymptomatic(s) uterin(s) fibroma(s) being able to interfere with the fertility by the patient who having an immediate or differed desire of pregnancy.
- Size: diameter ≥ 6 cm at echographia (for the highest diameter)
- Location interstitial and / or subserosa
- planned laparotomic surgery
- negative pregnancy test within 48 hours of surgery
Key exclusion criteria (7 listed)
- History of abdomino-pelvic surgery (except appendicectomy - cesarotomy)
- Pre-operative embolization
- Endometriosis stage >1 (American Fertility Society classification ≥ 5)
- Pregnant patient
- Diabetes
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 |
|---|---|---|
| Ringer lactate solutionAlso: Myomectomy by LaparotomyRinger lactate solution was applied directly onto the uterine surgical sites at the end of the myomectomy surgery, to prevent post-surgical adhesion formation. | Other | Ringer solution |
| Prevadh filmAlso: Myomectomy by LaparotomyPrevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation. | Device | Prevadh film |
Primary outcome
Number of Patients With Adhesions to Uterine Scars
Time frame: 10 to 20 weeks post surgery
The primary endpoint was the assessment of adhesions to uterine scars and comprised the incidence (expressed per patient and per uterine scar), extent, and severity of adhesions observed during the second-look laparoscopy performed 10 to 20 weeks after the myomectomy. This assessment was made by the surgeon (investigator) on the one hand and by two independent surgeons who reviewed the video recordings on the other hand.
3 secondary outcomes
Fertility
Time frame: 3 years
Adnexal Adhesions
Time frame: 10 to 20 weeks post surgery
mAFS Abdominopelvic Adhesion Score
Time frame: 10 to 20 weeks post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24841647Canis MJ, Triopon G, Darai E, Madelenat P, LeVeque J, Panel P, Fernandez H, Audebert A, Descamps P, Castaing N, Roman H, Fauconnier A, Benifla JL. Adhesion prevention after myomectomy by laparotomy: a prospective multicenter comparative randomized single-blind study with second-look laparoscopy to assess the effectiveness of PREVADH. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:42-7. doi: 10.1016/j.ejogrb.2014.03.020. Epub 2014 Apr 8.
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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.
BECKER Patrice study director
Sofradim Production
CANIS Michel, Pr principal investigator
University Hospital Estaing - 63003 CLERMONT-FERRAND Cedex
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ringer lactate solution and Prevadh film in people with Uterine Fibroids and Fertility Disorders, run by Medtronic - MITG at 11 sites in France.
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 6 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: finished, as of the sponsor's last update on 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Adhesions to Uterine Scars (time frame: 10 to 20 weeks post 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 NCT01388907, 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 17 Nov 2016.