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NCT01746628 · ClinicalTrials.gov registry record · NA
Intrauterine Use of FloSeal: Is it Safe and Useful?
A NA study of Operative Hemorrhage, sponsored by David L Zisow MD.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT01746628: Completed NA study of Operative Hemorrhage, sponsored by David L Zisow MD.
NCT01746628 is a NA study of Operative Hemorrhage that has completed, run by David L Zisow MD. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01746628, a NA study of Operative Hemorrhage, has completed, sponsored by David L Zisow MD.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study 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. 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
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Hysterectomy with FloSeal
Study Locations (1)
Maryland
- Northwest Hospital - Randallstown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-12 |
| Est. Completion | 2015-04 |
| Phase | NA |
What the finished NCT01746628 record still lists
NCT01746628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Operative Hemorrhage appearing as the primary indexed condition, and to 1 intervention - of which Hysterectomy with FloSeal is the first listed.
NCT01746628 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01746628 about?
NCT01746628 is a clinical study titled "Intrauterine Use of FloSeal: Is it Safe and Useful?". 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...
What is the current status of trial NCT01746628?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2012-12. Estimated completion is 2015-04.
What conditions does trial NCT01746628 study?
This clinical trial studies the following conditions: Operative Hemorrhage.
What interventions are being tested in trial NCT01746628?
The interventions under investigation include: Hysterectomy with FloSeal (PROCEDURE).
Who is sponsoring clinical trial NCT01746628?
This trial is sponsored by David L Zisow MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01746628 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01746628's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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