Sonography Guided Transcervical Ablation of Uterine Fibroids
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 25 - 50 |
Updated: | 2/21/2019 |
Start Date: | October 2014 |
End Date: | October 2019 |
Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance
The objective of this study is to establish the safety and effectiveness of the Sonata®
System in the treatment of symptomatic uterine fibroids.
System in the treatment of symptomatic uterine fibroids.
In this single-arm study, subjects who have symptomatic uterine fibroids will have
transcervical RF ablation of uterine fibroids under intrauterine ultrasound guidance using
the Gynesonics Sonata System.
transcervical RF ablation of uterine fibroids under intrauterine ultrasound guidance using
the Gynesonics Sonata System.
Inclusion Criteria:
- premenopausal
- ≥ 25 and ≤ 50 years of age at time of enrollment
- experienced heavy menstrual bleeding associated with fibroids (AUB-L) for at least 3
months
- between 1-10 fibroids of FIGO types 1, 2, 3, 4, and/or type 2-5, with diameter ≥ 1.0
cm and ≤ 5.0 cm
- at least one type 1, type 2, type 3, or type 2-5 fibroid.
- PBAC score ≥ 150 and ≤ 500
- consistent menstrual cycles
- not at material risk for pregnancy
- speaks and reads a language for which validated questionnaires are available
- willing and able to read, understand, and sign the informed consent form, to
participate in the study and to adhere to all study follow-up requirements
Exclusion Criteria:
- pregnancy
- urgent need for surgery to treat fibroid symptoms
- desire for current or future childbearing
- presence of a tubal implant for sterilization
- postmenopausal by history
- presence of type 0 fibroids, unless < 1 cm in diameter
- presence of a single polyp ≥ 1.5 cm, or multiple polyps of any size
- any fibroid of FIGO type 1, type 2, type 3, type 4, or type 2-5 with diameter > 5.0 cm
- bulk symptoms in the presence of one or more fibroids of FIGO type 5, type 6, or type
7
- exclusive presence of fibroids that are insufficient to explain the severity of
symptoms
- presence of clinically relevant fibroids that cannot be treated for technical reasons
- presence of an extrauterine pelvic mass that has not been diagnosed as benign
- IUD/IUS in situ within the washout period
- previous procedure for fibroids or heavy menstrual bleeding other than myomectomy
- myomectomy within 12 months
- any abnormality of the endometrial cavity that obstructs access of the handpiece
- contraindication to MRI
- total uterine volume > 1000 cc
- clinically significant adenomyosis
- confirmed or suspected diagnosis of clinically relevant endometriosis
- one or more clinically relevant fibroids that are significantly calcified.
- previous pelvic irradiation
- renal insufficiency [serum creatinine ≥ 1.5 mg/dL (132.6 μmol/L)]
- evidence of disorders of hemostasis (AUB-C)
- abnormal cervical cytology that is unevaluated or untreated in adherence with national
guidelines
- endometrial hyperplasia (AUB-M), including simple hyperplasia without atypia
- confirmed abdominal / pelvic malignancy within the previous five years
- active pelvic infection or current positive testing for pelvic gonorrhea or chlamydia;
- use of a hormonally-relevant medication within the washout period
- use of an antifibrinolytic agent while undergoing any screening procedures
- current use of anticoagulant therapy
- chronic pelvic pain (disruptive for at least six months) or significant baseline
pelvic or menstrual pain
- chronic uncontrolled moderate and severe hypertension
- hypoplastic or otherwise short uterus
- major medical or psychiatric illness or other factors that may affect general health
or subject's ability to adhere to the follow-up schedule or provide valid subject
self-assessment data
- any other reason for which the individual study subject is not appropriate or suitable
for participation
We found this trial at
23
sites
22 S Greene St
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Vadim Morozov, MD
Phone: 410-328-7791
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
Click here to add this to my saved trials
5050 Anthony Wayne Dr
Detroit, Michigan 48201
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: Jay M Berman, MD
Phone: 248-263-3612
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Joseph Hudgens, MD
Phone: 601-815-7038
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
Click here to add this to my saved trials
Norfolk, Virginia 23507
Principal Investigator: Khaled Sakhel, MD
Phone: 757-446-5080
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
Principal Investigator: Carrie Swartz, MD
Phone: 505-847-4100
Click here to add this to my saved trials
1 Cooper Plaza
Camden, New Jersey 08103
Camden, New Jersey 08103
(856) 342-2000
Principal Investigator: Saifuddin Mama, M.D.
Phone: 856-968-7547
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
Click here to add this to my saved trials
Denver, Colorado 80246
Principal Investigator: Michael Moore, MD
Phone: 303-321-2255
Click here to add this to my saved trials
Durham, North Carolina 27713
Principal Investigator: Andrea Lukes, MD
Phone: 919-251-9223
Click here to add this to my saved trials
Fort Lauderdale, Florida 33316
Principal Investigator: Khadra M. Osman, MD
Phone: 954-467-8049
Click here to add this to my saved trials
Fort Worth, Texas 76104
Principal Investigator: Alan Johns, MD
Phone: 817-922-2579
Click here to add this to my saved trials
Frisco, Texas 75035
Principal Investigator: Phyllis Gee, MD
Phone: 469-361-4007
Click here to add this to my saved trials
Greenville, South Carolina 29615
Principal Investigator: David Forstein, DO
Phone: 864-455-5951
Click here to add this to my saved trials
Monterrey, N.l. 64460
Principal Investigator: Jose G Garza-Leal, MD
Phone: 044-8183891111
Click here to add this to my saved trials
Naperville, Illinois 60540
Principal Investigator: Charles E Miller, MD
Phone: 630-364-1112
Click here to add this to my saved trials
New York, New York 10467
Principal Investigator: Scott Chudnoff, MD
Phone: 718-405-8386
Click here to add this to my saved trials
Newark, Delaware 19713
Principal Investigator: Gretchen E Makai, MD
Phone: 302-733-2112
Click here to add this to my saved trials
3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
Philadelphia, Pennsylvania 19102
Principal Investigator: Carl Della Badia, DO
Phone: 215-762-8582
Click here to add this to my saved trials
Phoenix, Arizona 85006
Principal Investigator: Kelly H. Roy, MD
Phone: 602-358-8588
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
Principal Investigator: Richard S Guido, MD
Phone: 412-641-6681
Click here to add this to my saved trials
Click here to add this to my saved trials
Seattle, Washington 98101
(888) 862-2737
Principal Investigator: Linda Mihalov, MD
Phone: 206-342-6910
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
Click here to add this to my saved trials
Click here to add this to my saved trials
Wellington, Florida 33414
Principal Investigator: Seth Herbst, MD
Phone: 561-231-5028
Click here to add this to my saved trials