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Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

Primary Purpose

Fibroid, Myoma, Leiomyoma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
SprayShield™
Sponsored by
Integra LifeSciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fibroid focused on measuring Adhesion, Fibroid, Myoma, Leiomyoma, Myomectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Pius Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SprayShield™

Control

Arm Description

SprayShield™

No adhesion barrier administered.

Outcomes

Primary Outcome Measures

Number of Sites Adherent to the Uterus
The number of times an adhesion is attached to the uterus.
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.
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.
Area of Sites Adherent to the Uterus (cm^2)

Secondary Outcome Measures

Full Information

First Posted
April 30, 2009
Last Updated
August 7, 2017
Sponsor
Integra LifeSciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00891657
Brief Title
Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integra LifeSciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 (SLL) following laparoscopic myomectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibroid, Myoma, Leiomyoma
Keywords
Adhesion, Fibroid, Myoma, Leiomyoma, Myomectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SprayShield™
Arm Type
Experimental
Arm Description
SprayShield™
Arm Title
Control
Arm Type
No Intervention
Arm Description
No adhesion barrier administered.
Intervention Type
Device
Intervention Name(s)
SprayShield™
Intervention Description
Anti-adhesion barrier
Primary Outcome Measure Information:
Title
Number of Sites Adherent to the Uterus
Description
The number of times an adhesion is attached to the uterus.
Time Frame
8-12 weeks post myomectomy
Title
Mean Severity Score of Sites Adherent to the Uterus
Description
The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.
Time Frame
8-12 weeks post myomectomy
Title
Mean Extent Score of Sites Adherent to the Uterus
Description
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.
Time Frame
8-12 weeks post myomectomy
Title
Area of Sites Adherent to the Uterus (cm^2)
Time Frame
8-12 weeks post myomectomy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females, 18 years of age or older, of child-bearing potential. Subject has at least one myoma >= 3 cm. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudy Leon De Wilde, MD
Organizational Affiliation
Pius Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pius Clinic
City
Oldenburg
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

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