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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 (SLL) following laparoscopic myomectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SprayShield™ | Experimental | SprayShield™ |
|
| Control | No Intervention | No adhesion barrier administered. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SprayShield™ | Device | Anti-adhesion barrier |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sites Adherent to the Uterus | The number of times an adhesion is attached to the uterus. | 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. | 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. | 8-12 weeks post myomectomy |
| Area of Sites Adherent to the Uterus (cm^2) | 8-12 weeks post myomectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rudy Leon De Wilde, MD | Pius Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pius Clinic | Oldenburg | Germany |
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Between November 10, 2008 and March 4, 2009, a total of 15 subjects were consented for potential participation, of whom all 15 subjects were randomized. There were no intra-operative screen failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | SprayShield™ | The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied. |
| FG001 | Control | The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SprayShield™ | The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Sites Adherent to the Uterus | The number of times an adhesion is attached to the uterus. | Number of subjects to have had a second laparoscopic look. | Posted | Mean | Standard Deviation | Adhesion Sites | 8-12 weeks post myomectomy |
|
10 November 2008 (first subject consented) to 09 May 2009 (last subject follow-up visit date)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SprayShield™ | The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epilepsy | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
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The very small sample size makes it difficult to detect any real differences between the treatments, if such differences exist.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Medical Affairs | Integra LifeSciences | 609-275-0500 |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D009214 | Myoma |
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Control |
The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Number of subjects to have had a second laparoscopic look. | Posted | Mean | Standard Deviation | Scores on a Scale | 8-12 weeks post myomectomy |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Scores on a Scale | 8-12 weeks post myomectomy |
|
|
|
| Primary | Area of Sites Adherent to the Uterus (cm^2) | Posted | Mean | Standard Deviation | cm^2 | 8-12 weeks post myomectomy |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Control | The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products. | 1 | 6 | 0 | 6 |
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| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |