Hemostatic Matrix in Endoscopic Sinus Surgery | NCT00242437

Studies
Hemostatic Matrix in Endoscopic Sinus Surgery

NCT00242437

Sponsor

Ethicon, Inc.

Status

Completed

Last Update Posted

Jul 13, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Sinusitis

Interventions

Hemostatic matrix
bovine thrombin

Countries

United States

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

Jul 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Not provided

Completion Date

Feb 2006

First Submitted Date

Oct 19, 2005

First Submission Date that Met QC Criteria

Oct 19, 2005

First Posted Date

Oct 20, 2005Estimated

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

Jul 11, 2006

Last Update Posted Date

Jul 13, 2006Estimated

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

Measure	Description	Time Frame
Success in achieving hemostasis after product application

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are 18 years or older.
Patients undergoing elective primary or re-do endoscopic sinus surgery for chronic sinusitis with bleeding surface requiring an adjunct to achieve hemostasis.
Patients must be willing and capable of cooperating to the extent and degree required by the protocol and sign the IRB approved Informed Consent Form prior to any participation in the study.

Exclusion Criteria:

Patients with bleeding diathesis, pathologic coagulopathy, systemic disorders, inflammatory conditions (other than chronic sinusitis or nasal polyposis) or autoimmune, immunodeficiency diseases or any other disorder that may interfere with hemostasis.
Patients with severe (brisk or forceful) bleeding site(s).
Patients undergoing urgent or emergency endoscopic sinus surgery.
Patients with bronchial asthma who have aspirin intolerance.
Patients with diffuse polyposis that would require chronic oral steroids or patients on chemotherapeutic agents that might delay healing (short term pulse steroid therapy and topical steroids are acceptable).
Patients who have used anticoagulant, antiplatelet or nonsteroidal anti-inflammatory analgesic (NSAID) within 7 days prior to surgery.
Patients who are morbidly obese (Body Mass Index > 35).
Patients with acute local infection at the operative side.
Patients who are current alcohol and/or drug abusers.
Patients with neoplasm, craniofacial abnormalities (e.g. cleft palate), or sleep apnea using nasal CPAP, or patients that may require a Lothrop procedure.
Female patients who are pregnant or nursing.
Patients who have uncontrolled diabetes mellitus (blood glucose levels >400 mg/dl) as determined by the Investigator based on medical history.
Patients who have participated in another investigational drug or device research within 30 days of enrollment.
Patients with known antibodies to bovine thrombin preparations, sensitivities or religious prohibitions to porcine gelatin or bovine components.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Hemostatic matrix	Device
bovine thrombin	Device

Facility	Status	City	State	ZIP	Country	Contacts
The Summit Medical GroupDepartment of Otolaryngology		Summit	New Jersey	07901	United States
The Medical University of South Carolina Department of Otolaryngology

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010254	Paranasal Sinus Diseases
D009668	Nose Diseases

Measure	Description	Time Frame
Post operative healing
Patient Satisfaction
Time to hemostasis