Tolerability of a Modified Health-Dx

Celero Systems

Status: Completed

Conditions: Healthy Volunteers

Treatments: Device: modified Health- Dx™ (mHDx) control capsule; Device: modified Health- Dx™ (mHDx) study capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT06240650

CEL-005

Details and patient eligibility

About

Single Blind, Randomized Control Study is designed to evaluate the tolerability of the Celero Systems' modified Health-Dx™ (mHDx) capsule.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy individuals ages 18 - 75 inclusive
• Subject is a suitable candidate for study participation in the opinion of the Investigator
• Subject has been informed of the nature of the study and has provided written informed consent as approved by the WVU IRB

Exclusion criteria

• Subjects with a history of any condition that may impact the GI tract
• Subjects who are unable to swallow a 000 sized capsule
• Subjects with an implanted medical device that has wireless data communication capability
• Subjects planning to undergo an MRI within 30 days after the study
• Subjects with a BMI > 40 (severe obesity)
• Subjects who are pregnant or are nursing
• Any subject deemed to be at risk of a gastrointestinal complication as evaluated by a gastroenterologist prior to study enrollment

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups

modified Health- Dx™ (mHDx) study capsule

Experimental group

Treatment:

Device: modified Health- Dx™ (mHDx) study capsule

modified Health- Dx™ (mHDx) control capsule

Other group

Treatment:

Device: modified Health- Dx™ (mHDx) control capsule