Hemostatic TechniquesPhase 2FleeceNCT00598130
Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy
A Phase 2 study testing Fleece in people with Hemostatic Techniques and Nephrectomy, run by OMRIX Biopharmaceuticals at 4 sites in Israel.
Trial summary
This is a prospective, randomized, single blind, standard care- controlled study, which will include a total of 30 patients divided into two treatment arms: First are: patents who will be treated in accordance with standard of care. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemostatic Techniques, Nephrectomy
- What is being tested?
- Fleece
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesIsrael
- Study dates
- Feb 2008to Feb 2009
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective open partial nephrectomy
- Patients must be willing to participate in the study, and provide written informed consent
Who cannot join
- Patients with a tumor diameter greater than 4 cm
- Any additional surgical intervention other than partial nephrectomy
- Patients with only one functional kidney
- Patients with known intolerance to blood products or other components of the product
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Bnei-Zion MC
Haifa
Meir MC
Kfar Saba
Rabin MC
Tel Aviv
Sheaba MC
Tel Aviv
About this study
Official title: A Prospective, Randomized, Single-Blind, Standard Care Controlled, Multi-Center, Phase II Study Evaluating the Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy
This is a prospective, randomized, single blind, standard care- controlled study, which will include a total of 30 patients divided into two treatment arms: First are: patents who will be treated in accordance with standard of care. Second arm: patients for which the Fibrin Fleece will be applied directly on the active bleeding site.
- Conditions
- Hemostatic Techniques, Nephrectomy
- Being tested
- Fleece
- Keywords
- Patients undergoing elective open partial nephrectomy surgery, Excision of a kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FleeceBiological
Fibrin Patch
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | patients who will be treated in accordance with standard of care Receives: Biological: Fleece |
| II | Active comparator | patients for which the Fibrin Fleece will be applied directly on the active bleeding site. Receives: Biological: Fleece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of successes at 10 minutes following randomization
Measured: 10 minutes
Secondary outcomes (1)
Proportion of successes at 5 minutes following randomization
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionNov 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemostatic TechniquesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OMRIX Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yoram Dekel, MD, Principal investigator, Rabin MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598130
- Sponsor's protocol ID
- FL-PN-002-IS
- Other IDs
- MoH
- Acronym
- Fleece
- Status last verified
- Nov 2009
- First submitted
- 23 Dec 2007
- Last updated
- 6 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nativ O, Patel B, Shen J, Batiller J, Horn S, Hart JC. Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: results of an open-label phase I and a randomized, standard-of-care-controlled phase I/II study. BMC Nephrol. 2012 Nov 8;13:147. doi: 10.1186/1471-2369-13-147.
PubMed 23137020
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-Blind, Standard Care Controlled, Multi-Center, Phase II Study Evaluating the Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT00598130
- Acronym / sponsor ID
- Fleece / FL-PN-002-IS
- Conditions
- Hemostatic Techniques, Nephrectomy
- Keywords
- Patients undergoing elective open partial nephrectomy surgery, Excision of a kidney
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- OMRIX BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 18 Jan 2008 (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.
This is a prospective, randomized, single blind, standard care- controlled study, which will include a total of 30 patients divided into two treatment arms: First are: patents who will be treated in accordance with standard of care. Second arm: patients for which the Fibrin Fleece will be applied directly on the active bleeding site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Biological: Fleecepatients who will be treated in accordance with standard of care |
| II | Active comparator | Biological: Fleecepatients for which the Fibrin Fleece will be applied directly on the active bleeding site. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective open partial nephrectomy
- Patients must be willing to participate in the study, and provide written informed consent
Key exclusion criteria (4 listed)
- Patients with a tumor diameter greater than 4 cm
- Any additional surgical intervention other than partial nephrectomy
- Patients with only one functional kidney
- Patients with known intolerance to blood products or other components of the product
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 |
|---|---|---|
| FleeceFibrin Patch | Biological | I, II |
Primary outcome
Proportion of successes at 10 minutes following randomization
Time frame: 10 minutes
1 secondary outcome
Proportion of successes at 5 minutes following randomization
Time frame: 5 minutes
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 6 Nov 2009.
- Derived from this study: PubMed 23137020Nativ O, Patel B, Shen J, Batiller J, Horn S, Hart JC. Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: results of an open-label phase I and a randomized, standard-of-care-controlled phase I/II study. BMC Nephrol. 2012 Nov 8;13:147. doi: 10.1186/1471-2369-13-147.
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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.
Yoram Dekel, MD principal investigator
Rabin MC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fleece in people with Hemostatic Techniques and Nephrectomy, run by OMRIX Biopharmaceuticals at 4 sites in Israel.
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 2 inclusion and 4 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 6 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportion of successes at 10 minutes following randomization (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00598130, which also lists 1 linked publication.
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 6 Nov 2009.