- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00131365
Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids
Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment.
Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.'
연구 개요
상세 설명
Background
General:
Uterine leiomyoma (fibroids) are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape, and often highly vascular. On T2 weighted MR imaging exams, or T1 exams with contrast, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid. In general, these symptoms can be classified into two categories:
- heavy menstrual bleeding, defined as bleeding on heavy days requiring a change of sanitary wear every 2 hours or less, significant clot passage, flooding, substantial prolongation of menstrual periods compared with the patient's prior experience, or anemia.
- pelvic pain or pressure, heaviness or discomfort, or similar symptoms in the back, flank or leg attributable to the bulk of the fibroid, urinary frequency, increase in nocturia, difficulty voiding or compression of the ureters with hydronephrosis.
Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement in the initial symptoms that caused her to seek treatment (decrease in pain, bladder or bowel symptoms, or reduction in vaginal bleeding), while experiencing a minimum of co-morbidities from the treatment itself.
ExAblate Device:
The InSightec ExAblate MR guided Focused Ultrasound Surgery (MRgFUS) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue. It has been evaluated in an earlier FDA international, multi-center study and found to be safe and effective for the treatment of uterine fibroids. ExAblate device received FDA approval in October 2004.
Prior Studies:
The ExAblate has been used for the treatment of uterine fibroids in 2 previous IDE protocols.
- Group A: This was the original Pivotal Study Group (IDE G020001 - Protocol UF002). These 109 patients were treated at 3 sites in the US and at 4 sites outside the US. There was a limitation on the allowable treatment volume and only a single treatment was permitted. Original follow-up was planned for 6 months. The study was later extended to include follow-up visits at 12, 24, and 36 months (UF009). Because of the gap between the initial study consent, and the re-consent for the long term follow-up there was a high dropout rate at the 12 month visit. Thirty-three US patients returned for the 12 months visit, and will continue to be followed for the 24 and 36 M visits.
- Group B: This was the Continued Access Study (IDE G020001 - Protocol UF005) where approximately 160 patients were treated at 3 sites in the US during the PMA review period. Treatment conditions were modified somewhat from the pivotal, including the addition of a second treatment session where necessary. The initial study was planned to include a long term follow-up of 12, 24 and 36 months (UF009).
- Group C: This group of 70 patients (UF14) will be treated post-PMA approval following the commercial treatment guidelines. The follow-up will include for visits at 12, 24 and 36 months. This group includes also another 20 patients who will be treated under this original IDE to validate the ExAblate system for use in a 3T MR scanner, as well as validating a new application SW (V4.1).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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New York
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New York, New York, 미국, 10022
- Cornell Vascular
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-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
- Able and willing to give consent and able to attend all study visits.
- Patient is pre or peri-menopausal (within 12 months of last menstrual period).
- Able to communicate sensations during the ExAblate procedure.
- Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).
- Fibroids(s) clearly visible on non-contrast magnetic resonance imaging (MRI).
Exclusion Criteria:
- Metallic implants that are incompatible with MRI
- Sensitive to MRI contrast agents
- Severe claustrophobia that would prevent completion of procedure in MR unit
- Women who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
- Pedunculated fibroids
- Active pelvic inflammatory disease (PID)
- Active local or systemic infection
- Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia
- Intrauterine device (IUD) anywhere in the treatment path
- Dermoid cyst of the ovary anywhere in the treatment path
- Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries)
- Undiagnosed vaginal bleeding
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: ExAblate MRgFUS
Treatment with the ExAblate 2000 system Version 4.1
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number and Type of Adverse Events
기간: 36 months
|
Adverse events outcomes are reported in the adverse events module.
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36 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Robert Min, M.D., Cornell Vascular
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UF014 - 4.1/3T
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
ExAblate 2000에 대한 임상 시험
-
Matthew BucknorFocused Ultrasound Foundation; InSightec-TxSonics모병
-
Mayo ClinicEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)완전한