High-intensity Focused Ultrasound in Treatment of Uterine... | NCT02954757

Studies
High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis

NCT02954757

Sponsor

Queen Mary Hospital, Hong Kong

Status

Unknown status

Last Update Posted

Sep 18, 2020Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Adenomyosis

Interventions

HIFU treatment

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Mar 2021Estimated

Completion Date

Jun 2021Estimated

First Submitted Date

Oct 20, 2016

First Submission Date that Met QC Criteria

Nov 1, 2016

First Posted Date

Nov 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2020

Last Update Posted Date

Sep 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Uterine adenomyosis is a common uterine benign condition. They can cause abnormal menstrual bleeding, and menstrual pain. Although surgical intervention is the definitive treatment, some women prefer to have their uterus preserved. High-intensity focused ultrasound (HIFU) therapy is receiving increasing interest in the management of uterine adenomyosis by inducing focal thermocoagulation of the fibroids. Results obtained by various research groups have shown that HIFU treatment is safe, effective and is highly acceptable to patients. The main objective of this study is to evaluate the therapeutic efficacy of HIFU in the treatment of uterine adenomyosis.

In this proposed study, 10 patients who have symptomatic uterine adenomyosis who meet the study inclusion criteria will be invited to participate in the study which involves the use of HIFU in the management of the adenomyosis. Background information of the patients such as age, body mass index, hormonal (pre- or postmenopausal) status and the presence of chronic medical disease will be collected. Subjects will also be asked to complete an eight-item section of a Uterine Fibroid Symptom and Quality Of Life Questionnaire (UFS-QOL) and menstrual pain score which evaluate the effect of the adenomyosis on the quality of life of women.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment arm	Experimental	HIFU treatment	Procedure: HIFU treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HIFU treatment	Procedure	High intensity focused ultrasound	Treatment arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Perceived symptoms change after HIFU treatment By using the menstrual pain score	By using the menstrual pain score for pain evaluation at each follow up (i.e. from baseline to post 1- month, post 1-month to post 3-month, post 3-month to post 6-month, post 6-month to post 12-month treatment will be captured).	The changes from baseline to post 12-month treatment will be captured

Secondary Outcomes

Measure	Description	Time Frame
Perceived symptoms change after HIFU treatment By using the Uterine Fibroid Symptoms Quality Of Life Questionnaire (UFS_QOL)	By using the Uterine Fibroid Symptoms Quality Of Life Questionnaire (UFS_QOL) for symptoms evaluation at each follow up (i.e. from baseline to post 1- month, post 1-month to post 3-month, post 3-month to post 6-month, post 6-month to post 12-month treatment will be captured)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >40 years old, with no future childbearing plans
Age >30 years old, who has tubal sterilization
Significant symptoms related to adenomyosis, intractable to standard medical therapy, or patient considering radiological intervention (uterine fibroid embolization) or surgery.
Clinical uterine size less than 20 weeks gestation
Localized adenomyotic lesion or adenomyoma identified of less than 10 cm in diameter as judged by contrast MRI, involving only anterior or posterior uterine wall and not both.
No laparotomy scars.
Women should be able to give consent.

Exclusion Criteria:

Other pelvic or uncontrolled systemic diseases
Confirmed or suspected pregnancy
Patients who are unable to communicate with researchers during the treatment
Patients who are contraindicated for MRI examination
Patients with thick abdominal wall (>5 cm, as measured by MRI)
Presence or history of acute pelvic inflammatory disease or any pelvic malignancy
History of lower abdominal surgery, known severe pelvic endometriosis and/ or extensive pelvic adhesion
Presence of significant sized fibroids which may interfere with the treatment or affect the outcome measures

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Vincent YT Cheung, MBBS, FRCOG	Queen Mary Hospital, Hong Kong	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D062788	Adenomyosis

Ancestor Terms

ID	Term
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

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Browse Branches

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