Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy | NCT01187680

Studies
Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy

NCT01187680

Sponsor

Radboud University Medical Center

Status

Terminated

Last Update Posted

Dec 29, 2010Estimated

Enrollment

16Actual

Phase

Phase 4

Conditions

Postoperative Adhesion
Peritoneal Adhesion, Nos

Interventions

Spraygel
Control

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Financial and organisational reasons

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

Apr 2004Actual

Completion Date

Jul 2009Actual

First Submitted Date

Jul 19, 2010

First Submission Date that Met QC Criteria

Aug 23, 2010

First Posted Date

Aug 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2010

Last Update Posted Date

Dec 29, 2010Estimated

Name	Class
Onze Lieve Vrouwe Gasthuis	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to investigate whether sprayable PEG barrier is effective in reducing adhesions in laparoscopic gynecologic surgery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Label	Type	Description	Intervention Names
Spraygel	Experimental		Device: Spraygel
Control	Active Comparator		Device: Control

Name	Type	Description	Arm Group Labels	Other Names
Spraygel	Device		Spraygel
Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
successful adhesion prevention	Adhesion prevention was defined as successful if no de novo fromed adhesion were found at second look laparoscopy.

Secondary Outcomes

Measure	Description	Time Frame
LABS adhesion score
Adhesion sites	Reduction in the number of sites covered with adhesions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>18 years
Undergoing gynecologic laparoscopy

Exclusion Criteria:

Suspected malignancy
Incomplete adhesiolysis during initial laparoscopy
Pregnancy
Lactating
Stage IV endometriosis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Onze Lieve Vrouwe Gasthuis		Amsterdam	North Holland		Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D046248	Pyloric Stenosis, Hypertrophic
D000267	Tissue Adhesions

Ancestor Terms

ID	Term
D011707	Pyloric Stenosis
D017219	Gastric Outlet Obstruction
D013272	Stomach Diseases
D005767	Gastrointestinal Diseases

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Browse Branches

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