Sonograms Enable Looking Forward- Get Your iNformation 1 Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 365
- 试验地点
- 4
- 主要终点
- Net Promoter Score (NPS)
研究概览
简要总结
This clinical trial will evaluate the efficacy and safety of the use of the Turtle Health Ultrasound Scanner for the acquisition of transvaginal ultrasound images by a study participant, with no previous training, in her home when guided by real-time remote supervision from a qualified and specially trained ultrasound technologist.
详细描述
Those images will be assessed for their image quality by qualified Independent Readers. The study is intended to assess the ability of at home imaging performed with the Turtle Health Ultrasound Scanner to reliably produce quality images as compared to objective performance criteria set by the American Institute of Ultrasound in Medicine (AIUM).
The clinical investigation is intended to extend the findings of a published trial (SELF-HELP) to real-world performance.
Each participant will have imaging performed at-home. The at-home imaging will be conducted using the Turtle Health Ultrasound Scanner, manipulated by the participant and guided in real time by a remote ultrasound technologist that has received special training with the device. Home imaging will follow the procedures included in planned device labeling. Imaging obtained will include, at minimum, each of the specific imaging views and components defined in the "American Institute of Ultrasound in Medicine (AIUM) Case Study Submission Requirements: Gynecologic Ultrasound".
Imaging Scans will be assessed by at least two (2) independent readers who are physicians expert in the interpretation of transvaginal ultrasound gynecologic imaging studies. Images will have participant name redacted and each independent reader will be blinded to any participant information other than the images themselves. They will also be blinded to the assessments of the other readers. In-clinic Imaging Scans obtained from either or both of previous trials and in-clinic scans will be included in rating batches for calibration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Independent Readers reviewing Imaging Exams will be fully blinded to participant health history and exam setting.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman, as defined by sex at birth
- •Age 22 years or older at the time of eligibility screening
- •Premenopausal
- •BMI < 40 kg/m2
- •Unlikely to be pregnant during home scan, based on either current intrauterine device (IUD) or other birth control use or recent menstruation, defined as the home scan occurring between day 3 and 10 of the menstrual cycle based on patient self-report
- •English-speaking and able to follow verbal instructions of the remote ultrasound technologist as determined by the ability to complete the consent process unassisted
- •Ability to manipulate a 1 lb. weight by hand
- •Residence in state where a PI holds a valid license to practice medicine
- •Ability to receive signature delivery of the investigational ultrasound device
- •Ability to return the investigational ultrasound device by specified instructions
排除标准
- •Pregnant or may be pregnant
- •Has recently given birth, and has had fewer than 3 postpartum menstrual cycles
- •Has 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
- •Has changed birth control within the current menstrual cycle (one 'washout' cycle is required)
- •Turtle Health employees
- •Has known cancer of a pelvic organ, not currently in remission
- •Not able to schedule a scan while meeting the requirements above prior to the end of the trial. For example, women who change birth control within the last cycle of the trial (and would require a 'washout cycle' that would delay trial close) or who are unable to schedule within the last few weeks of the trial after reasonable scheduling efforts have been made
- •Previous hysterectomy or oophorectomy
- •Does not have one or more of the following anatomic organs: vagina, left ovary, right ovary, or uterus
- •Subjects with prior scanning experience are included in the trial (as they would be in the real world) but excluded from the primary image quality endpoint (due to experience potentially influencing that endpoint) and analyzed separately as a subgroup for that endpoint only. This sub-population is capped at 200 subjects (~20% of trial)
结局指标
主要结局
Net Promoter Score (NPS)
时间窗: 6 weeks
All subjects will be asked to complete the question 'How likely are you to recommend the experience to a friend or colleague?.' It is expected that a high share of patients will report a positive NPS.
Image Quality
时间窗: 6 weeks
Each Independent Reader will make a determination of whether each Imaging Scan is of 'diagnostic quality' or 'not diagnostic quality', in its totality, for the purpose of a diagnostic gynecological ultrasound examination.
次要结局
- False Positives(6 weeks)
- Timely Return(6 weeks)
- Shipping Damage(6 weeks)
- Minor Pain or Discomfort(6 weeks)
- All Other Adverse Events(6 weeks)
- Performance Task of Independent Readers(6 weeks)
- Box Opening(6 weeks)
- Patient Identifier(6 weeks)
- Successful Return(6 weeks)
- Probe Cover(6 weeks)
- Correct Cavity(6 weeks)
- Ultrasound technologist satisfaction(6 months)
- Ultrasound technologist safety(6 months)
- Correct setting of care guess rate(6 months)
- Ultrasound technologist availability(6 months)
- Successful Reprocessing(6 weeks)
- Sub-group exploratory endpoints: Endpoint 1(1 year)
- Sub-group exploratory endpoints: Endpoint 2(1 year)