SinusitisPhase 4NCT00242437
Hemostatic Matrix in Endoscopic Sinus Surgery
A Phase 4 study testing Hemostatic matrix and bovine thrombin in people with Sinusitis, run by Ethicon, Inc. at 3 sites in United States.
Trial summary
Evaluating clinical performance of Hemostatic Matrix with bovine thrombin in achieving hemostasis in patients undergoing endoscopic sinus surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis
- What is being tested?
- Hemostatic matrix and bovine thrombin
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2005to Feb 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Medical University of South Carolina Department of Otolaryngology
Charleston, South Carolina, 29425-0550
University of Tennessee Department of Otolaryngology
Memphis, Tennessee, 38163
The Summit Medical GroupDepartment of Otolaryngology
Summit, New Jersey, 07901
About this study
Official title: A Prospective, Multicenter Study to Evaluate Hemostatic Matrix With Bovine Thrombin in Achieving Hemostasis in Patients Undergoing Endoscopic Sinus Surgery
Evaluating clinical performance of Hemostatic Matrix with bovine thrombin in achieving hemostasis in patients undergoing endoscopic sinus surgery.
- Conditions
- Sinusitis
- Being tested
- Hemostatic matrix, bovine thrombin
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemostatic matrixDevice
bovine thrombinDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Success in achieving hemostasis after product application
Secondary outcomes (3)
Post operative healing
Patient Satisfaction
Time to hemostasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startOct 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Hart, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242437
- Sponsor's protocol ID
- 400-05-002
- Status last verified
- Jul 2006
- First submitted
- 19 Oct 2005
- Last updated
- 13 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study to Evaluate Hemostatic Matrix With Bovine Thrombin in Achieving Hemostasis in Patients Undergoing Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT00242437
- Acronym / sponsor ID
- 400-05-002
- Conditions
- Sinusitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Feb 2006
- First posted
- 20 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating clinical performance of Hemostatic Matrix with bovine thrombin in achieving hemostasis in patients undergoing endoscopic sinus surgery.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemostatic matrix | Device | – |
| bovine thrombin | Device | – |
Primary outcome
Success in achieving hemostasis after product application
3 secondary outcomes
Post operative healing
Patient Satisfaction
Time to hemostasis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Hart, MD study director
Ethicon, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hemostatic matrix and bovine thrombin in people with Sinusitis, run by Ethicon, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success in achieving hemostasis after product application. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2006.