NCT07006090招募中不适用
A Prospective, Observational, Post-Market Registry to Collect Real-World Clinical Data on the Use of the Histolog Scanner in Multiple Disease Areas.
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Number of confirmed medical interventions based on Histolog® image readings.
研究概览
简要总结
The goal of this observational study is to gather real-world evidence on the performance and safety of the Histolog® Scanner (HLS) when used as intended. HLS is a real-time ex-vivo tissue imaging device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old at the time of consenting
- •Undergoing a surgery or a medical procedure with use of Histolog® Scanner
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Active participation in a drug, device, or other medical intervention study that has not reached its primary endpoint at the time of consenting
- •Patients under judicial protection, legal guardianship or curatorship.
研究组 & 干预措施
Adult patients undergoing a surgery or a medical procedure with use of Histolog® Scanner
unique cohort in the study
干预措施: Histolog Scanner (Device)
结局指标
主要结局
Number of confirmed medical interventions based on Histolog® image readings.
时间窗: From enrolment to diagnosis confirmation at post surgery follow-up visit (V2: 37 days after enrolment)
次要结局
- Concordance between the assessment of Histolog® images and the final pathology assessment expressed as sensitivity, specificity, positive predictive value, and negative predictive value(From enrolment to post surgery follow-up visit (V2: 37 days after enrolment))
- Re-operation rates if Histolog® used for intra-operative assessment(From surgery (V1: Day 0) to post surgery follow-up visit (V2: +30 days))
- Cancer-free survival up to 5 years of follow-up(From enrolment to the end of 5 years follow-up)
- Evaluation of usage patterns across different indications and application profiles.(From enrolment to the end of 5 years follow-up.)
- Device deficiency defined as any inadequacy in the identity, quality, durability, reliability, safety or performance of a device, including malfunction, use errors or inadequacy in information supplied by the manufacturer.(From first patient surgery visit (V1: Day 0) to last patient surgery visit.)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Prospective Case Registry for WoundsWound Healing DelayedNCT05898698Kerecis Ltd.300
已完成
不适用
MANTA Registry for Vascular Large-bore ClosureFemoral Arteriotomy ClosureNCT03330002Essential Medical, Inc.500
终止
不适用
Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data CollectionCerebral AneurysmNCT02281721Stryker Neurovascular150
已完成
不适用
A Real-World Observational Study for the Safety and Efficacy of Baraclude in Korean Pediatric Patients With Chronic Hepatitis BHepatitis BNCT03426618Bristol-Myers Squibb1
招募中
不适用
Ethicon Pelvic Mesh Post Market Clinical Follow-up RegistryPelvic Organ ProlapseStress Urinary IncontinenceNCT04829175Ethicon, Inc.1,000