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Home Examinations Researching and Understanding Submucosal Evaluations (HER-USE)

Primary Purpose

Fertility Issues

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional other trial for Fertility Issues

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Virtual metasite

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

Sensitivity of the at-home ultrasound for submucosal fibroids

Qualified independent raters will be asked if they see a submucosal fibroid on the uterine videos. Answer options are: Yes, definitely; Almost certain; Possibly; Unlikely; No; N/A. In order to consider a fibroid present, either (1) two raters must answer "Almost certain" to having seen a submucosal fibroid or (2) one must answer "Yes definitely" to having seen a submucosal fibroid

Secondary Outcome Measures

Full Information

NCT ID

NCT05004870

First Posted

August 6, 2021

Last Updated

April 25, 2022

Sponsor

Turtle Health, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05004870

Brief Title

Home Examinations Researching and Understanding Submucosal Evaluations

Acronym

HER-USE

Official Title

Home Examinations Researching and Understanding Submucosal Evaluations: Prospective, Virtual Study to Demonstrate Sensitivity of Submucosal Fibroids on At-home Ultrasound (Follow up to SELF-HELP Study)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Study objective embedded into future study

Study Start Date

December 16, 2021 (Anticipated)

Primary Completion Date

December 17, 2021 (Anticipated)

Study Completion Date

December 17, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Turtle Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fertility Issues

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Sensitivity of the at-home ultrasound for submucosal fibroids

Description

Time Frame

Up to 20 minutes

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Virtual metasite

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Home Examinations Researching and Understanding Submucosal Evaluations

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