We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 4 for:    imbiotechnologies

Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02410018
Recruitment Status : Completed
First Posted : April 7, 2015
Results First Posted : September 7, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
IMBiotechnologies Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Leiomyomata Device: OCL 503 (uterine artery embolization) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: 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.

Device: OCL 503 (uterine artery embolization)
Transcatheter embolization of the uterine artery(ies) using an embolic agent.

Experimental: 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.

Device: OCL 503 (uterine artery embolization)
Transcatheter embolization of the uterine artery(ies) using an embolic agent.




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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.


Secondary Outcome Measures :
  1. Tissue Necrosis Assessed by Histology Graded Scale at 7 Days Post Treatment of Women With Leiomyomata by UAE [ Time Frame: 7 days ]
    Tissue necrosis assessed by histology at 7 days post treatment of women with leiomyomata by UAE - Fibroid necrosis observed

  2. Inflammatory Response Assessed by Histology 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 - Perivascular inflammation - Low Grade

  3. Tissue Necrosis Assessed by Histology Graded Scale at 28 Days Post Treatment of Women With Leiomyomata by UAE [ Time Frame: 28 days ]
    Tissue necrosis assessed by histology graded scale at 28 days post treatment of women with leiomyomata by UAE - Fibroid Necrosis

  4. Inflammatory Response Assessed by Histology 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 - Perivascular Low Grade



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410018


Locations
Layout table for location information
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Sponsors and Collaborators
IMBiotechnologies Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Gary Siskin, MD Albany Medical College
Layout table for additonal information
Responsible Party: IMBiotechnologies Ltd.
ClinicalTrials.gov Identifier: NCT02410018    
Other Study ID Numbers: OCL503-P1-UFE-01
First Posted: April 7, 2015    Key Record Dates
Results First Posted: September 7, 2018
Last Update Posted: December 5, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases