Home Examinations Researching and Understanding Submucosal Evaluations

NCT ID: NCT05004870

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-16
• Study Completion Date: 2021-12-17

Brief Summary

To demonstrate that imaging via home ultrasound can identify submucosal fibroids. The image quality and submucosal fibroid detection specificity of the home imaging has already been demonstrated; the aim of this study is to generate further data for sensitivity. This will be a single visit study, with participants scanning themselves at home with healthcare professional (HCP) supervision. Targeted population is women with previously diagnosed submucosal fibroids that have not been removed. The study will be single-blinded to the image raters.

Conditions

Fertility Issues

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Women with a known history of submucosal fibroids (that have not been surgically removed)

Group Type: EXPERIMENTAL

Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)

Intervention Type: DEVICE

The ultrasound device used is cleared for HCP-supervised use in environments where healthcare is provided by trained HCPs. No changes to the design or manufacture have been made for this study.

Interventions

Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)

The ultrasound device used is cleared for HCP-supervised use in environments where healthcare is provided by trained HCPs. No changes to the design or manufacture have been made for this study.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Women with one or more submucosal fibroid, with appropriate attestation (see more detail below)
• Women between the ages of 18 and 49 inclusive (women 38 and younger can also receive their antral follicle count, or AFC; 39 and older will participate in uterine scanning only)
• Women with BMI up to 40
• Women located in states where the PI or sub-PI licensure is valid
• Women able to freely give consent electronically, given COVID. For the purposes of this study, this is defined as women who speak native or fluent English; and have a high school degree or equivalent, and who are otherwise, in the professional judgement of the PI, able to give informed consent

Exclusion Criteria

• Women with expert ultrasound experience, e.g., ultrasound technologists, radiologists, OB/GYNs, Reproductive Endocrinologists
• Women with BMI over 40
• Women who do not speak English natively or fluently
• Women who have recently given birth, and have had fewer than 3 postpartum menstrual cycles
• Women who have recently had a stillbirth or abortion more than 20 weeks (subject to the 3 postpartum menstrual cycles above). Miscarriages or abortions less than 20 weeks are subject to two wait cycles
• Women who are currently pregnant or may be pregnant
• Any woman the PI believes is not capable of giving independent, informed consent
• Turtle Health employees

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Turtle Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Virtual metasite

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

010

Identifier Type: -

Identifier Source: org_study_id