Clinical Performance of the ID-Cap System, an Ingestion Event Marker, in the Clinical Setting as an Aid to Measure Medication Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Positive Detection Accuracy (PDA)
研究概览
简要总结
The ID-Cap System is classified as an ingestion event marker (IEM), a Class II medical device. The system is intended to record time-stamped ingestions with the ingestible sensor, ID-Tag which transmits a signal to a wearable device, the ID-Cap Reader. In this study, 36 subjects will ingest capsules containing ingestible sensors while wearing the Reader and being observed in a clinic setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Capsules are identical in appearance. Only unblinded pharmacy personnel at the study site will be aware of the ingestion allocation of active ID-Capsules or placebo capsules.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women 18 years of age or older.
- •Enroll at least one subject and less than four subjects 65 years of age or older
- •Enroll at least one subject and less than four subjects 18 to 21 years of age
- •For females of childbearing potential, negative urine pregnancy test at time of entry and assurance that a medically-accepted means of contraception will be used for the duration of the study. Able and willing to provide informed consent.
- •Willing to adhere to all protocol requirements and study procedures.
- •Adequate organ function at screening (defined for investigator in protocol)
排除标准
- •Unable to take oral medications.
- •Women who are pregnant, breast-feeding, or plan to become pregnant during the study, and females of childbearing potential who are not using a medically-accepted means of contraception.
- •Medical condition which may affect passage through the gastrointestinal tract
- •Known hypersensitivity to any component of the ingestible ID-Capsule
- •Significant medical condition, psychiatric condition, current alcohol or drug abuse, or other condition which may preclude the study participant from being able to follow study procedures or to safely participate in the opinion of the investigator..
- •Participation in an investigational product study (e.g., medical device or drug study) within 30 days prior to screening, or prior participation in an Ingestion Event Marker study.
- •Presence of an active implantable electronic medical device.
- •Positive screen for drugs of abuse (detection of drug for which a valid prescription exists is not exclusionary)
研究组 & 干预措施
ID-Capsules- Active
Randomly-assigned ingestions of ID-Capsules containing ingestible sensors (ID-Capsule- Active) while wearing the ID-Cap Reader (Wearable Sensor) under direct observation
• Subjects will ingest ID-Capsules containing the ingestible sensor which emits a signal from within the subject's stomach. This signal is detected by the wearable Reader, and the ingestion event is recorded.
干预措施: ID-Capsule- Active (Device)
ID-Capsules- Active
Randomly-assigned ingestions of ID-Capsules containing ingestible sensors (ID-Capsule- Active) while wearing the ID-Cap Reader (Wearable Sensor) under direct observation
• Subjects will ingest ID-Capsules containing the ingestible sensor which emits a signal from within the subject's stomach. This signal is detected by the wearable Reader, and the ingestion event is recorded.
干预措施: Wearable Sensor (Device)
ID-Capsules- Inactive
Randomly-assigned ingestions of ID-Capsules containing no ingestible sensors while wearing the ID-Cap Reader under direct observation
• Subjects will also ingest empty placebo capsules that do not contain ingestible sensors. In the absence of an ingested sensor, no signal is received by the Reader after the capsule is ingested, and the ingestion event is not recorded.
干预措施: Wearable Sensor (Device)
ID-Capsules- Inactive
Randomly-assigned ingestions of ID-Capsules containing no ingestible sensors while wearing the ID-Cap Reader under direct observation
• Subjects will also ingest empty placebo capsules that do not contain ingestible sensors. In the absence of an ingested sensor, no signal is received by the Reader after the capsule is ingested, and the ingestion event is not recorded.
干预措施: Placebo (Device)
结局指标
主要结局
Positive Detection Accuracy (PDA)
时间窗: Up to 10 days
The number of active ingestible sensors detected divided by the number of active ingestible sensors administered under direct observation.
Negative Detection Accuracy (NDA)
时间窗: Up to 10 days
The number of inactive empty capsules not detected divided by the number of inactive empty capsules administered under direct observation. Determination of NDA will also include the number of monitoring periods with no ingestion events detected by the Reader divided by the number of specific monitoring periods performed for the purpose of detecting false positives.
次要结局
- Number of Study Participants with Adverse Events as a Measure of Safety and Tolerability(Up to 10 days during ingestion events through the follow-up assessment scheduled within 3 to 5 days of the last ingestion)