LeiomyomataNCT02410018
Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata
A study testing OCL 503 (uterine artery embolization) in people with Leiomyomata, run by IMBiotechnologies Ltd. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leiomyomata
- What is being tested?
- OCL 503 (uterine artery embolization)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- presence of one or more of the following symptoms: abnormal menstrual bleeding, prolonged menstrual period, pelvic pain, or bulk-related symptoms that are attributed to uterine fibroids (bulk-related symptoms include pelvic pressure, abdominal distension, abdominal bloating, constipation, backache, urinary frequency, urinary retention, ureteral dilation, and rectal pressure), and the intensity of uterine fibroid-related symptoms, which are sufficiently sever to warrant hysterectomy, and the patient's medical history, physical examination, and the results of imaging by ultrasound or MRI;
- are between the ages of 30 and 55 years, inclusive;
- have had a pelvic examination by a gynaecologist within the previous 6 months;
- have had a normal Pap smear within the last 12 months;
- have had an endometrial biopsy within the previous three to six months, as appropriate to patient history;
- are premenopausal with menstrual cycles lasting between 22 and 35 days. A follicle stimulating hormone (FSH) value obtained within three months prior to the procedure must be < 40 IU/L;
- are scheduled for total abdominal hysterectomy;
- are willing and able to provide written, informed consent.
Who cannot join
- have been treated with gonadotropin-releasing hormone (GnRH) agonists within the previous 12 weeks;
- have a American Society of Anesthesiologists (ASA) score ≥ 3;
- have abnormally large ovarian arteries, as assessed by MRA and determined by the Investigator;
- have an undiagnosed pelvic mass outside the uterus;
- have claustrophobia or other contraindications to the performance of the pre- and post-procedure MRI studies including the presence of metal implants, metal plates, bone pins, bone screws, neurostimulators, cardiac pacemakers, aneurysm clips, cochlear or retinal implants, permanent hearing aids, or permanent eye-liner;
- have pedunculated subserosal fibroids with an attachment to the uterus less than one third of the greatest diameter of the fibroid;
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- who do not agree to use contraceptives from Visit 1 until undergoing total abdominal hysterectomy;
- have compromised hematopoietic function;
- have hepatic dysfunction defined as liver function tests 30% above the upper limit of normal;
- have an active gynecologic or systemic infection;
- have renal dysfunction as defined by a serum creatinine > 1.5 mg/dL
- have a history of gynecologic malignancy;
- have had a documented anaphylactic reaction to a drug or anesthetic, or an allergic reaction to iodine contrast media not controlled by antihistamines or steroids;
- have received other investigational drugs or who have had experimental therapy within the past four weeks or are participating in any other concurrent experimental therapy;
- have a uterine volume < 250 mL or approximately > 24 weeks gestation;
- have known endometrial hyperplasia, adenomyosis, or pelvic inflammatory disease;
- have abnormal coagulation profiles;
- are allergic to bovine collagen;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Single Center, Pilot Study to Evaluate the Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata Scheduled for Hysterectomy
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.
Read the detailed description
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.
- Conditions
- Leiomyomata
- Being tested
- OCL 503 (uterine artery embolization)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCL 503 (uterine artery embolization)Device
Transcatheter embolization of the uterine artery(ies) using an embolic agent.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OCL 503 (uterine artery embolization) |
| 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. Receives: Device: OCL 503 (uterine artery embolization) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline and 28 days
Secondary outcomes (4)
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
Measured: 7 days
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
Measured: 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
Measured: 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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeiomyomataStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMBiotechnologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Siskin, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410018
- Sponsor's protocol ID
- OCL503-P1-UFE-01
- Status last verified
- Nov 2018
- First submitted
- 6 Mar 2015
- Last updated
- 5 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Center, Pilot Study to Evaluate the Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata Scheduled for Hysterectomy
- ClinicalTrials.gov ID
- NCT02410018
- Acronym / sponsor ID
- OCL503-P1-UFE-01
- Conditions
- Leiomyomata
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- IMBiotechnologies Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Posted 7 Sep 2018
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, pilot, open-label, uncontrolled, safety and effectiveness study of uterine artery embolization with OCL 503 in women with leiomyomata who are scheduled for hysterectomy.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Uterine Artery Embolization | Experimental | Device: OCL 503 (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. |
| Cohort 2 - Uterine Artery Embolization | Experimental | Device: OCL 503 (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. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- presence of one or more of the following symptoms: abnormal menstrual bleeding, prolonged menstrual period, pelvic pain, or bulk-related symptoms that are attributed to uterine fibroids (bulk-related symptoms include pelvic pressure, abdominal distension, abdominal bloating, constipation, backache, urinary frequency, urinary retention, ureteral dilation, and rectal pressure), and the intensity of uterine fibroid-related symptoms, which are sufficiently sever to warrant hysterectomy, and the patient's medical history, physical examination, and the results of imaging by ultrasound or MRI;
- are between the ages of 30 and 55 years, inclusive;
- have had a pelvic examination by a gynaecologist within the previous 6 months;
- have had a normal Pap smear within the last 12 months;
- have had an endometrial biopsy within the previous three to six months, as appropriate to patient history;
Key exclusion criteria (18 listed)
- have been treated with gonadotropin-releasing hormone (GnRH) agonists within the previous 12 weeks;
- have a American Society of Anesthesiologists (ASA) score ≥ 3;
- have abnormally large ovarian arteries, as assessed by MRA and determined by the Investigator;
- have an undiagnosed pelvic mass outside the uterus;
- have claustrophobia or other contraindications to the performance of the pre- and post-procedure MRI studies including the presence of metal implants, metal plates, bone pins, bone screws, neurostimulators, cardiac pacemakers, aneurysm clips, cochlear or retinal implants, permanent hearing aids, or permanent eye-liner;
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 |
|---|---|---|
| OCL 503 (uterine artery embolization)Transcatheter embolization of the uterine artery(ies) using an embolic agent. | Device | Cohort 1 - Uterine Artery Embolization, Cohort 2 - Uterine Artery Embolization |
Primary outcome
Number of Participants With Serious Adverse Events
Time frame: 7 days
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
Change in Fibroid Perfusion From Baseline at 7 Days Post Treatment
Time frame: Baseline and 7 days
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.
Number of Participants With Serious Adverse Events
Time frame: 28 days
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
Change in Fibroid Perfusion From Baseline at 28 Days Post Treatment of Women With Leiomyomata by UAE
Time frame: Baseline and 28 days
Number of participants with decreased fibroid perfusion from baseline at 28 days post treatment of women with leiomyomata by UAE.
4 secondary outcomes
Tissue Necrosis Assessed by Histology Graded Scale at 7 Days Post Treatment of Women With Leiomyomata by UAE
Time frame: 7 days
Inflammatory Response Assessed by Histology at 7 Days Post Treatment of Women With Leiomyomata by UAE
Time frame: 7 days
Tissue Necrosis Assessed by Histology Graded Scale at 28 Days Post Treatment of Women With Leiomyomata by UAE
Time frame: 28 days
Inflammatory Response Assessed by Histology at 28 Days Post Treatment of Women With Leiomyomata by UAE
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Leiomyomata
RecruitingObservational study
Specimen and Data Study for Ovarian Cancer Early Detection and Prevention
Cervical Cancer, Endometrial Cancer
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.
Gary Siskin, MD principal investigator
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCL 503 (uterine artery embolization) in people with Leiomyomata, run by IMBiotechnologies Ltd. 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?
The sponsor lists 8 inclusion and 18 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 5 Dec 2018. 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. 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?
Yes. Results are posted in the registry (first posted 7 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Serious Adverse Events (time frame: 7 days). The study lists 4 primary outcomes in all. 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 5 Dec 2018; AzTrials last refreshed its copy on 8 Nov 2026.