Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT00891657
First received: April 30, 2009
Last updated: September 4, 2014
Last verified: September 2014
Results First Received: July 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: Fibroid
Myoma
Leiomyoma
Intervention: Device: SprayShield™

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
Control The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.

Participant Flow:   Overall Study
    SprayShield™     Control  
STARTED     9     6  
COMPLETED     8     5  
NOT COMPLETED     1     1  
Withdrawal by Subject                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Control The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
Total Total of all reporting groups

Baseline Measures
    SprayShield™     Control     Total  
Number of Participants  
[units: participants]
  9     6     15  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     6     15  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  35.8  ± 4.6     44.3  ± 3.3     39.2  ± 5.9  
Gender  
[units: participants]
     
Female     9     6     15  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Germany     9     6     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Sites Adherent to the Uterus   [ Time Frame: 8-12 weeks post myomectomy ]

2.  Primary:   Mean Severity Score of Sites Adherent to the Uterus   [ Time Frame: 8-12 weeks post myomectomy ]

3.  Primary:   Mean Extent Score of Sites Adherent to the Uterus   [ Time Frame: 8-12 weeks post myomectomy ]

4.  Primary:   Area of Sites Adherent to the Uterus (cm^2)   [ Time Frame: 8-12 weeks post myomectomy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The very small sample size makes it difficult to detect any real differences between the treatments, if such differences exist.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Global Director, Clinical Affairs - BioSurgery
Organization: Confluent Surgical
phone: 781.839.1770
e-mail: jennifer.doyle@covidien.com


No publications provided


Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT00891657     History of Changes
Other Study ID Numbers: GYN-08-002
Study First Received: April 30, 2009
Results First Received: July 13, 2010
Last Updated: September 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices