Operative HemorrhageNCT01746628
Intrauterine Use of FloSeal: Is it Safe and Useful?
A study testing Hysterectomy with FloSeal in people with Operative Hemorrhage, run by David L Zisow MD LLC at 1 site in United States.
Trial summary
When having certain types of outpatient surgery inside the uterine cavity some women experience heavy bleeding. The only method presently available for controlling such bleeding, short of removing the uterus, involves the placement of a balloon pressure device inside the uterine cavity. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Operative Hemorrhage
- What is being tested?
- Hysterectomy with FloSeal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Apr 2015
- Phase
- Interventional
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria:Women undergoing hysterectomy for non-malignant indications -
Exclusion Criteria:Malignancy Inability to remove uterus without morcellation
-
Trial locations and contacts
1 site in 1 country.
About this study
When having certain types of outpatient surgery inside the uterine cavity some women experience heavy bleeding. The only method presently available for controlling such bleeding, short of removing the uterus, involves the placement of a balloon pressure device inside the uterine cavity. The pressure along with the patient's own natural clotting ability will generally stop the bleeding. However, this treatment usually requires at least a 24 hour stay in the hospital. The investigators are researching the use of a compound (FloSeal) already approved for use in other areas of the human body, as a method of controlling bleeding. The use of FloSeal in the uterine cavity has not yet been tested and therefore is not yet an FDA approved indication for its safe use to control bleeding from the uterine cavity. In this study, The investigators want to find out what effect(s) FloSeal has on the uterine cavity.
Twenty individuals will be included in this study at Northwest Hospital Center. All twenty individuals will be treated in the same fashion except ten of the participants will randomly be assigned to receive FloSeal and ten will not.
Read more
Study participants are individuals currently scheduled to have a hysterectomy procedure, which involves surgically removing the uterus from the body for a previously determined standard of care treatment for a non- cancerous medical problem. Before performing the hysterectomy and evaluating the effects of FloSeal upon the tissues within the uterine cavity the following will be done. Once under anesthesia the uterine cavity will be subjected to a curettage (sharp scrapping) to produce a minor amount of bleeding from the lining of the uterus. Ten of the 20 study participants, randomly chosen, will then have FloSeal placed into their uterine cavity. The study participants will not know whether they received FloSeal or not. A balloon pressure device will then be placed into the uterine cavity of all 20 individuals and left in place for 5 minutes. After the allotted time, the balloon device will be removed. The hysterectomy will then be completed appropriately using standard methods and techniques. The uterus, once removed will be evaluated pathologically to determine the effects of the FloSeal upon the tissues of the cavity in those so treated and compared to the same analysis in those individuals who did not receive FloSeal. The pathologist will not know which patients received or did not receive FloSeal.
This use of FloSeal is not currently an FDA approved use of the compound. The goal of this study is to obtain FDA approval for use in this situation.
Read the detailed description
Patients will be followed until fully recovered from surgery, usually 6 to 8 weeks. Any complications will be duly noted and treated appropriately. The final end point for follow up will be when the patient is finally discharged from care having achieved what is usually perceived as a return to all normal activity.
- Conditions
- Operative Hemorrhage
- Being tested
- Hysterectomy with FloSeal
- Keywords
- type 0 myomata, type 1 myomata, type 2 myomata, bleeding, hemorrhage, hysteroscopy, FloSeal
- Medical subject headings
- Blood Loss, Surgical, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysterectomy with FloSealProcedure or surgery
Also called Endometrial curettage, FloSeal placement into uterine cavity, Intrauterine foley balloon placement for 5 minutes, Removal of intrauterine foley balloon
Evaluation of the effects of intrauterine FloSeal
| Study group | Role | What they receive |
|---|---|---|
| Hysterectomy without FloSeal | Placebo comparator | Endometrial curettage Intrauterine foley balloon placement for 5 minutes Removal of intrauterine foley balloon Saline irrigation of uterine cavity Hysterectomy Receives: Procedure: Hysterectomy with FloSeal |
| Hysterectomy with FloSeal | Active comparator | Endometrial curettage FloSeal placement into uterine cavity Intrauterine foley balloon placement for 5 minutes Removal of intrauterine foley balloon Saline irrigation of uterine cavity Hysterectomy Receives: Procedure: Hysterectomy with FloSeal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue effects of FloSeal upon endometrium on day 1
Pathological (microscopic and histochemical) evaluation of endometrial curettings and uterine specimens in all study cases to evaluate immediate (day 1) tissue effects of FloSeal upon the endometrium.
Measured: Immediate post operative effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Operative HemorrhageStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- David L Zisow MD LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, David L Zisow, MD, David L Zisow MD LLC
- Investigators
- David L Zisow, MD, Principal investigator, LifeBridge Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746628
- Sponsor's protocol ID
- 1971
- Status last verified
- Jan 2016
- First submitted
- 6 Dec 2012
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Use of FloSeal: Is it Safe and Useful?
- ClinicalTrials.gov ID
- NCT01746628
- Acronym / sponsor ID
- 1971
- Conditions
- Operative Hemorrhage
- Keywords
- type 0 myomata, type 1 myomata, type 2 myomata, bleeding, hemorrhage, hysteroscopy, FloSeal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- David L Zisow MD LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 11 Dec 2012 (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.
When having certain types of outpatient surgery inside the uterine cavity some women experience heavy bleeding. The only method presently available for controlling such bleeding, short of removing the uterus, involves the placement of a balloon pressure device inside the uterine cavity. The pressure along with the patient's own natural clotting ability will generally stop the bleeding. However, this treatment usually requires at least a 24 hour stay in the hospital. The investigators are researching the use of a compound (FloSeal) already approved for use in other areas of the human body, as a method of controlling bleeding. The use of FloSeal in the uterine cavity has not yet been tested and therefore is not yet an FDA approved indication for its safe use to control bleeding from the uterine cavity. In this study, The investigators want to find out what effect(s) FloSeal has on the uterine cavity.
Twenty individuals will be included in this study at Northwest Hospital Center. All twenty individuals will be treated in the same fashion except ten of the participants will randomly be assigned to receive FloSeal and ten will not.
Study participants are individuals currently scheduled to have a hysterectomy procedure, which involves surgically removing the uterus from the body for a previously determined standard of care treatment for a non- cancerous medical problem. Before performing the hysterectomy and evaluating the effects of FloSeal upon the tissues within the uterine cavity the following will be done. Once under anesthesia the uterine cavity will be subjected to a curettage (sharp scrapping) to produce a minor amount of bleeding from the lining of the uterus. Ten of the 20 study participants, randomly chosen, will then have FloSeal placed into their uterine cavity. The study participants will not know whether they received FloSeal or not. A balloon pressure device will then be placed into the uterine cavity of all 20 individuals and left in place for 5 minutes. After the allotted time, the balloon device will be removed. The hysterectomy will then be completed appropriately using standard methods and techniques. The uterus, once removed will be evaluated pathologically to determine the effects of the FloSeal upon the tissues of the cavity in those so treated and compared to the same analysis in those individuals who did not receive FloSeal. The pathologist will not know which patients received or did not receive FloSeal.
This use of FloSeal is not currently an FDA approved use of the compound. The goal of this study is to obtain FDA approval for use in this situation.
Detailed description
Patients will be followed until fully recovered from surgery, usually 6 to 8 weeks. Any complications will be duly noted and treated appropriately. The final end point for follow up will be when the patient is finally discharged from care having achieved what is usually perceived as a return to all normal activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hysterectomy without FloSeal | Placebo comparator | Procedure: Hysterectomy with FloSealEndometrial curettage Intrauterine foley balloon placement for 5 minutes Removal of intrauterine foley balloon Saline irrigation of uterine cavity Hysterectomy |
| Hysterectomy with FloSeal | Active comparator | Procedure: Hysterectomy with FloSealEndometrial curettage FloSeal placement into uterine cavity Intrauterine foley balloon placement for 5 minutes Removal of intrauterine foley balloon Saline irrigation of uterine cavity Hysterectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Hysterectomy with FloSealAlso: Endometrial curettage, FloSeal placement into uterine cavity, Intrauterine foley balloon placement for 5 minutes, Removal of intrauterine foley balloonEvaluation of the effects of intrauterine FloSeal | Procedure or surgery | Hysterectomy with FloSeal, Hysterectomy without FloSeal |
Primary outcome
Tissue effects of FloSeal upon endometrium on day 1
Time frame: Immediate post operative effects
Pathological (microscopic and histochemical) evaluation of endometrial curettings and uterine specimens in all study cases to evaluate immediate (day 1) tissue effects of FloSeal upon the endometrium.
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 21 Jan 2016.
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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.
David L Zisow, MD principal investigator
LifeBridge Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysterectomy with FloSeal in people with Operative Hemorrhage, run by David L Zisow MD LLC at 1 site 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?
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 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Tissue effects of FloSeal upon endometrium on day 1 (time frame: Immediate post operative effects). 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 21 Jan 2016.