Healthy VolunteersNCT06240650
Tolerability of a Modified Health-Dx
A study testing modified Health- Dx™ (mHDx) study capsule in people with Healthy Volunteers, run by Celero Systems, Inc. at 1 site in United States.
Trial summary
Single Blind, Randomized Control Study is designed to evaluate the tolerability of the Celero Systems' modified Health-Dx™ (mHDx) capsule. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- modified Health- Dx™ (mHDx) study capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2023to 2 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: Randomized Controlled Study to Evaluate Tolerability of a Modified Health-Dx
Single Blind, Randomized Control Study is designed to evaluate the tolerability of the Celero Systems' modified Health-Dx™ (mHDx) capsule.
- Conditions
- Healthy Volunteers
- Being tested
- modified Health- Dx™ (mHDx) study capsule, modified Health- Dx™ (mHDx) control capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Health- Dx™ (mHDx) study capsuleDevice
The Study mHDx capsule has a mechanism that allows the mHDx to remain resident in the stomach for no more than six (6) hours. After this residency period, the Study mHDx will disassemble and pass safely through the subject's gastrointestinal system.
modified Health- Dx™ (mHDx) control capsuleDevice
The Control mHDX capsule does not have a functional residency mechanism so it will disassemble once safely through the esophagus (within 10 minutes) and will then pass safely through the subject's gastrointestinal system.
| Study group | Role | What they receive |
|---|---|---|
| modified Health- Dx™ (mHDx) study capsule | Experimental | Not described Receives: Device: modified Health- Dx™ (mHDx) study capsule |
| modified Health- Dx™ (mHDx) control capsule | Other | Not described Receives: Device: modified Health- Dx™ (mHDx) control capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference, if any, in tolerability between the Study and Control as reported via the study questionnaire. mHDx as reported by the subjects.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start26 Jul 2023
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celero Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240650
- Sponsor's protocol ID
- CEL-005
- Status last verified
- Aug 2024
- First submitted
- 28 Dec 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study to Evaluate Tolerability of a Modified Health-Dx
- ClinicalTrials.gov ID
- NCT06240650
- Acronym / sponsor ID
- CEL-005
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Celero Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single Blind, Randomized Control Study is designed to evaluate the tolerability of the Celero Systems' modified Health-Dx™ (mHDx) capsule.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified Health- Dx™ (mHDx) study capsule | Experimental | Device: modified Health- Dx™ (mHDx) study capsule |
| modified Health- Dx™ (mHDx) control capsule | Other | Device: modified Health- Dx™ (mHDx) control capsule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified Health- Dx™ (mHDx) study capsuleThe Study mHDx capsule has a mechanism that allows the mHDx to remain resident in the stomach for no more than six (6) hours. After this residency period, the Study mHDx will disassemble and pass safely through the subject's gastrointestinal system. | Device | modified Health- Dx™ (mHDx) study capsule |
| modified Health- Dx™ (mHDx) control capsuleThe Control mHDX capsule does not have a functional residency mechanism so it will disassemble once safely through the esophagus (within 10 minutes) and will then pass safely through the subject's gastrointestinal system. | Device | modified Health- Dx™ (mHDx) control capsule |
Primary outcome
The difference, if any, in tolerability between the Study and Control as reported via the study questionnaire. mHDx as reported by the subjects.
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified Health- Dx™ (mHDx) study capsule in people with Healthy Volunteers, run by Celero Systems, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference, if any, in tolerability between the Study and Control as reported via the study questionnaire. mHDx as reported by the subjects. (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.