ID-Cap System Under Direct Observation

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT03475485

Run by

EtectRX, Inc.

People needed

36

Starts

2018-03-22

Expected to finish

2018-06-01

Last updated by the study team

2018-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Quotient Sciences — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.