FibroidNCT00891657

Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

A study testing SprayShield™ in people with Fibroid and Myoma, run by Integra LifeSciences Corporation at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Fibroid, Myoma, Leiomyoma
What is being tested?: SprayShield™
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteGermany
Study dates: Nov 2008to May 2009
Phase: Interventional
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Females, 18 years of age or older, of child-bearing potential.
Subject has at least one myoma >= 3 cm.

Who cannot join

Pregnant or lactating females.
Females undergoing prior open or closed myomectomy for treatment of myomas.
Evidence of current active endometriosis or infection
History of or active inflammatory bowel disease or pelvic inflammatory disease.
Presence of a frozen pelvis, or hydrosalpinges.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Pius Clinic
Oldenburg

Other trials in Germany

About this study

Official title: A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy

Conditions: Fibroid, Myoma, Leiomyoma
Being tested: SprayShield™
Keywords: Adhesion, Fibroid, Myoma, Leiomyoma, Myomectomy
Medical subject headings: Leiomyoma, Myoma, Tissue Adhesions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SprayShield™Device
Anti-adhesion barrier

Study groups in NCT00891657
Study group	Role	What they receive
SprayShield™	Experimental	SprayShield™ Receives: Device: SprayShield™
Control	No intervention	No adhesion barrier administered.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Sites Adherent to the Uterus
The number of times an adhesion is attached to the uterus.
Measured: 8-12 weeks post myomectomy
Mean Severity Score of Sites Adherent to the Uterus
The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.
Measured: 8-12 weeks post myomectomy
Mean Extent Score of Sites Adherent to the Uterus
0 =no adhesions, 1=covering <25% of locations' total area, 2=covering 26% to 50% of locations' total area, and 3=covering >51% of locations' total area.
Measured: 8-12 weeks post myomectomy
Area of Sites Adherent to the Uterus (cm^2)
Measured: 8-12 weeks post myomectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008May 2009

First posted1 May 2009 (estimated)
Study startNov 2008
Primary completionMay 2009
Study completionMay 2009

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.
Other trials for FibroidStudies 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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00891657
Sponsor's protocol ID: GYN-08-002
Status last verified: Aug 2017
First submitted: 30 Apr 2009
Last updated: 7 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
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Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
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RecruitingObservational study
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All Fibroid trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy
ClinicalTrials.gov ID: NCT00891657
Acronym / sponsor ID: GYN-08-002
Conditions: Fibroid, Myoma, Leiomyoma
Keywords: Adhesion, Fibroid, Myoma, Leiomyoma, Myomectomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 1 May 2009 (estimated)
Results: Posted 31 Aug 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
SprayShield™	Experimental	Device: SprayShield™SprayShield™
Control	No intervention	–No adhesion barrier administered.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Females, 18 years of age or older, of child-bearing potential.
Subject has at least one myoma >= 3 cm.

Key exclusion criteria (5 listed)

Pregnant or lactating females.
Females undergoing prior open or closed myomectomy for treatment of myomas.
Evidence of current active endometriosis or infection
History of or active inflammatory bowel disease or pelvic inflammatory disease.
Presence of a frozen pelvis, or hydrosalpinges.

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
SprayShield™Anti-adhesion barrier	Device	SprayShield™

Primary outcome

Number of Sites Adherent to the Uterus
Time frame: 8-12 weeks post myomectomy
The number of times an adhesion is attached to the uterus.
Mean Severity Score of Sites Adherent to the Uterus
Time frame: 8-12 weeks post myomectomy
The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.
Mean Extent Score of Sites Adherent to the Uterus
Time frame: 8-12 weeks post myomectomy
0 =no adhesions, 1=covering <25% of locations' total area, 2=covering 26% to 50% of locations' total area, and 3=covering >51% of locations' total area.
Area of Sites Adherent to the Uterus (cm^2)
Time frame: 8-12 weeks post myomectomy

Results and safety

Results posted to the registry on 31 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SprayShield™	9	8
Control	6	5

Primary outcome: Number of Sites Adherent to the Uterus

Time frame: 8-12 weeks post myomectomy. Mean (Standard Deviation). Unit: Adhesion Sites

Measure	SprayShield™ n = 8	Control n = 5
Value	1.1 (1.0)	0.6 (0.9)

Population analysed: Number of subjects to have had a second laparoscopic look.

Primary outcome: Mean Severity Score of Sites Adherent to the Uterus

Time frame: 8-12 weeks post myomectomy. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	SprayShield™ n = 8	Control n = 5
Value	1.63 (1.06)	0.8 (1.1)

Population analysed: Number of subjects to have had a second laparoscopic look.

Primary outcome: Mean Extent Score of Sites Adherent to the Uterus

Time frame: 8-12 weeks post myomectomy. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	SprayShield™ n = 8	Control n = 5
Value	0.92 (0.66)	0.6 (0.89)

Primary outcome: Area of Sites Adherent to the Uterus (cm^2)

Time frame: 8-12 weeks post myomectomy. Mean (Standard Deviation). Unit: cm^2

Measure	SprayShield™ n = 8	Control n = 5
Value	2.19 (2.32)	2.7 (5.24)

Adverse events

Time frame: 10 November 2008 (first subject consented) to 09 May 2009 (last subject follow-up visit date). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SprayShield™	0 of 9 (0%)	0 of 9 (0%)	Not reported
Control	1 of 6 (16.7%)	0 of 6 (0%)	Not reported

Limitations and caveats (from the sponsor): The very small sample size makes it difficult to detect any real differences between the treatments, if such differences exist.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Fibroid

Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy

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.

Rudy Leon De Wilde, MD principal investigator

Pius Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SprayShield™ in people with Fibroid and Myoma, run by Integra LifeSciences Corporation at 1 site in Germany.

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 5 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 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2010). 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 Sites Adherent to the Uterus (time frame: 8-12 weeks post myomectomy). The study lists 4 primary outcomes in all. 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 NCT00891657.

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 7 Sep 2017.