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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Oxytocin in MRI-HIFU

Clinicaltrials.gov identifier NCT03937401

Recruitment Status Enrolling by invitation

First Posted May 3, 2019

Last update posted May 3, 2019

Study Description

Brief summary:

Capability of oxytocin in improving the efficacy of MRI-HIFU is studied. Patients undergoing MRI-HIFU treatment are given oxytocin during treatment and the efficacy of the treatment will be analysed by patient reported symptom questionnaires and imaging data.

  • Condition or Disease:Fibroid
    Adenomyosis
  • Intervention/Treatment: Drug: Oxytocin
  • Phase: Phase 4
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Use of Oxytocin in MRI-HIFU Treatment
  • Actual Study Start Date: February 2019
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: January 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Patients treated with oxytocin during MRI-HIFU
Drug: Oxytocin
Oxytocin infusion during MRI-HIFU treatment
Outcome Measures
  • Primary Outcome Measures: 1. NPV [ Time Frame: up to one year ]
    non perfused volume (percentage of fibroid destroyed)
  • 2. duration of MRI-HIFU [ Time Frame: up to one year ]
    duration of MRI-HIFU treatment
  • 3. UFS-Qol [ Time Frame: 12 months after HIFU treatment ]
    Uterine fibroid symptom severity and quality of life (patient quality of life questionnaire)
Eligibility Criteria
  • Ages Eligible for Study: 18 to 50 Years (Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Patients undergoing MRI-HIFU -treatment

- Patients assessed for suitability to MRI-HIFU treatment

- willingness to participate in trial

Exclusion Criteria:

- Known allergy to Syntocinon/oxytocin

- Elevated blood pressure

- ischemic heart disease

- Long QT- interval

Contacts and Locations
Contacts
Locations

Finland
Turku University Hospital
Turku

Sponsors and Collaborators

Turku University Hospital

More Information
  • Responsible Party: Turku University Hospital
  • ClinicalTrials.gov Identifier: NCT03937401 History of Changes
  • Other Study ID Numbers: T366/2017
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: May 3, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: Individual participant data will not be shared with other researchers
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Turku University Hospital: fibroid
    oxytocin
    MRI-HIFU
    adenomyosis
  • Additional relevant MeSH terms: Leiomyoma Adenomyosis