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This is a prospective, pilot, open-label, uncontrolled, safety and effectiveness study of uterine artery embolization with OCL 503 in women with leiomyomata who are scheduled for hysterectomy.
Patients will be allocated to Cohort 1 or Cohort 2. Following pelvic angiogram to delineate the uterine vasculature, embolization procedures of the left and right uterine arteries (as required) will be performed on each patient, using OCL 503 as the embolic agent. Patients in Cohort 1 will proceed to hysterectomy 1 week after embolization, and patients in Cohort 2 will undergo hysterectomy 1 month after embolization. Tumor response, as measured by changes in leiomyomata size and perfusion, will be determined by Magnetic Resonance Imaging or Magnetic Resonance Angiography. Histology of the resected uterus will be conducted to evaluate inflammatory response and viable tumour tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - Uterine Artery Embolization | Experimental | Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. |
|
| Cohort 2 - Uterine Artery Embolization | Experimental | Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCL 503 (uterine artery embolization) | Device | Transcatheter embolization of the uterine artery(ies) using an embolic agent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events | Short-term safety of OCL 503 at 7 days post treatment of women with leiomyomata by UAE, as measured by Adverse Events reporting - Serious Adverse Events | 7 days |
| Change in Fibroid Perfusion From Baseline at 7 Days Post Treatment | Number of participants with decreased fibroid perfusion from baseline at 7 days post treatment of women with leiomyomata by UAE - Decreased Fibroid Perfusion Fibroid perfusion indicative of blood flowing to the fibroid at baseline and 7 days after embolization was determined using MRI. | Baseline and 7 days |
| Number of Participants With Serious Adverse Events | Short-term safety of OCL 503 at 28 days post treatment of women with leiomyomata by UAE, as measured by Adverse Events reporting - Serious Adverse Events | 28 days |
| Change in Fibroid Perfusion From Baseline at 28 Days Post Treatment of Women With Leiomyomata by UAE | Number of participants with decreased fibroid perfusion from baseline at 28 days post treatment of women with leiomyomata by UAE. | Baseline and 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue Necrosis Assessed by Histology Graded Scale at 7 Days Post Treatment of Women With Leiomyomata by UAE | Tissue necrosis assessed by histology at 7 days post treatment of women with leiomyomata by UAE - Fibroid necrosis observed | 7 days |
| Inflammatory Response Assessed by Histology at 7 Days Post Treatment of Women With Leiomyomata by UAE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Siskin, MD | Albany Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical Center | Albany | New York | 12208 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 - Uterine Artery Embolization | Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent. |
| FG001 | Cohort 2 - Uterine Artery Embolization | Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 - Uterine Artery Embolization | Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Serious Adverse Events | Short-term safety of OCL 503 at 7 days post treatment of women with leiomyomata by UAE, as measured by Adverse Events reporting - Serious Adverse Events | Posted | Count of Participants | Participants | 7 days |
|
Day 0 through 28 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 - Uterine Artery Embolization | Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fibroid expulsion | Reproductive system and breast disorders | Non-systematic Assessment | Expulsion of embolized fibroid from the uterine cavity. Note: risk of this adverse event is lost upon the study subject undergoing standard of care hysterectomy. All study subjects underwent hysterectomy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-embolization Syndrome | Investigations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| President | IMBiotechnologies Ltd | 780-945-6609 | mstewart@tbwifi.ca |
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| ID | Term |
|---|---|
| D055357 | Uterine Artery Embolization |
| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
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Inflammatory response assessed by histology at 7 days post treatment of women with leiomyomata by UAE - Perivascular inflammation - Low Grade |
| 7 days |
| Tissue Necrosis Assessed by Histology Graded Scale at 28 Days Post Treatment of Women With Leiomyomata by UAE | Tissue necrosis assessed by histology graded scale at 28 days post treatment of women with leiomyomata by UAE - Fibroid Necrosis | 28 days |
| Inflammatory Response Assessed by Histology at 28 Days Post Treatment of Women With Leiomyomata by UAE | Inflammatory response assessed by histology at 28 days post treatment of women with leiomyomata by UAE - Perivascular Low Grade | 28 days |
| BG001 |
| Cohort 2 - Uterine Artery Embolization |
Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Primary | Change in Fibroid Perfusion From Baseline at 7 Days Post Treatment | Number of participants with decreased fibroid perfusion from baseline at 7 days post treatment of women with leiomyomata by UAE - Decreased Fibroid Perfusion Fibroid perfusion indicative of blood flowing to the fibroid at baseline and 7 days after embolization was determined using MRI. | Posted | Count of Participants | Participants | Baseline and 7 days |
|
|
|
| Primary | Number of Participants With Serious Adverse Events | Short-term safety of OCL 503 at 28 days post treatment of women with leiomyomata by UAE, as measured by Adverse Events reporting - Serious Adverse Events | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Primary | Change in Fibroid Perfusion From Baseline at 28 Days Post Treatment of Women With Leiomyomata by UAE | Number of participants with decreased fibroid perfusion from baseline at 28 days post treatment of women with leiomyomata by UAE. | Decrease in fibroid perfusion | Posted | Count of Participants | Participants | Baseline and 28 days |
|
|
|
| Secondary | Tissue Necrosis Assessed by Histology Graded Scale at 7 Days Post Treatment of Women With Leiomyomata by UAE | Tissue necrosis assessed by histology at 7 days post treatment of women with leiomyomata by UAE - Fibroid necrosis observed | Histological assessment of uterine tissue was conducted for Cohort 1 at 7-days, post-embolization. Histological assessment of uterine tissue was conducted for Cohort 2 at 28-days, post-embolization. | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Inflammatory Response Assessed by Histology at 7 Days Post Treatment of Women With Leiomyomata by UAE | Inflammatory response assessed by histology at 7 days post treatment of women with leiomyomata by UAE - Perivascular inflammation - Low Grade | Inflammatory response for Cohort 1 was assessed at 7-days, post-embolization. Inflammatory response for Cohort-2 was assessed at 28-days, post-embolization. | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Tissue Necrosis Assessed by Histology Graded Scale at 28 Days Post Treatment of Women With Leiomyomata by UAE | Tissue necrosis assessed by histology graded scale at 28 days post treatment of women with leiomyomata by UAE - Fibroid Necrosis | Histological assessment of uterine tissue was conducted at 7-days for Cohort 1 and 28-days for Cohort 2, post-embolization. | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | Inflammatory Response Assessed by Histology at 28 Days Post Treatment of Women With Leiomyomata by UAE | Inflammatory response assessed by histology at 28 days post treatment of women with leiomyomata by UAE - Perivascular Low Grade | Inflammatory response was conducted at 7-days post-embolization for Cohort 1 and 28-days for Cohort 2, post-embolization. | Posted | Count of Participants | Participants | 28 days |
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| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Cohort 2 - Uterine Artery Embolization | Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent. | 0 | 1 | 0 | 1 | 1 | 1 |
|
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| D013509 |
| Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |