NCT07808034

Brief Summary

To assess the efficacy of High-Intensity Focused Ultrasound on adenomyosis

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
27mo left

Started Sep 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Dec 2028

First Submitted

Initial submission to the registry

September 3, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

September 16, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

2.3 years

First QC Date

September 3, 2026

Last Update Submit

September 3, 2026

Conditions

Keywords

adenomyosislower urinary tract symptomssexual dysfunctiongastrointestinal symptoms

Outcome Measures

Primary Outcomes (1)

  • Dysmenorrhea

    The changes of VAS scores of dysmenorrhea

    6 months

Secondary Outcomes (6)

  • Menorrhagia

    6 months

  • Overactive bladder symptoms

    6 months

  • Female sexual function

    6 months

  • Bowel incontinence

    6 months

  • Overall condition of dysmenorrhea

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Adenomyosis

adenomyosis of the uterus

Procedure: High Intensity Focused Ultrasound

Interventions

MRI guided High Intensity Focused Ultrasound

Adenomyosis

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with symptomatic uterine adenomyosis:

You may qualify if:

  • The patient must be at least 18 years old.
  • Adenomyosis: There must be several dark areas on at least one side of the uterine wall; the uterine wall must be thickened; in addition, the thickened uterine wall must have a nonhomogeneous structure; and clinically, there must be dysmenorrhea or menorrhagia.

You may not qualify if:

  • The patient currently has an acute lower urinary tract infection or intestinal inflammation.
  • The patient has previously undergone bladder or urethral surgery.
  • The patient has a history of urinary tract stones or tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Conditions

AdenomyosisLower Urinary Tract SymptomsSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 8, 2026

Study Start

September 16, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

September 8, 2026

Record last verified: 2026-09

Locations