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

NCT02410018 | Completed Results

• 1 other identifier: OCL503-P1-UFE-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Leiomyomata

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• Tissue Necrosis Assessed by Histology Graded Scale at 7 Days Post Treatment of Women With Leiomyomata by UAE

  7 days

• Inflammatory Response Assessed by Histology at 7 Days Post Treatment of Women With Leiomyomata by UAE

  7 days

• Tissue Necrosis Assessed by Histology Graded Scale at 28 Days Post Treatment of Women With Leiomyomata by UAE

  28 days

• Inflammatory Response Assessed by Histology at 28 Days Post Treatment of Women With Leiomyomata by UAE

  28 days

Study Arms (2)

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.

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.

Device: OCL 503 (uterine artery embolization)

Interventions

OCL 503 (uterine artery embolization) DEVICE

Transcatheter embolization of the uterine artery(ies) using an embolic agent.

Cohort 1 - Uterine Artery Embolization; Cohort 2 - Uterine Artery Embolization

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• IMBiotechnologies Ltd.: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

MeSH Terms

Interventions

Uterine Artery Embolization

Intervention Hierarchy (Ancestors)

Embolization, Therapeutic; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: President
• Organization: IMBiotechnologies Ltd

mstewart@tbwifi.ca

780-945-6609

Study Officials

• Gary Siskin, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: April 7, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 5, 2018
• Results First Posted: September 7, 2018

Record last verified: 2018-11

Locations

US (1)