Gastric DiseaseNCT06212206
PillBot™ - Remotely Controlled Capsule Endoscopy
A study testing PillBot in people with Gastric Disease, run by Endiatx.
Trial summary
The PillBot System is an endoscopic capsule imaging system intended for visualization of the stomach. In contrast to currently used passive capsule endoscopy systems, and FDA cleared active magnetic system, the PillBot System uses active, motorized propulsion technology to facilitate the navigation and positioning of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Disease
- What is being tested?
- PillBot
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Ability to provide written, informed consent to undergo both capsule endoscopy (un-sedated) and conventional OGD
- Willing and able to complete study follow-up requirements
- Patient has appropriate indications for upper endoscopy including symptoms of, but not limited to upper abdominal pain, acid reflux, heartburn, iron deficiency anemia, weight loss, bloating, belching, nausea, vomiting and atypical chest pain
Who cannot join
- All patients who meet any of the following criteria should not be enrolled into the study:
- Coagulopathy with INR > 1.5, thrombocytopenia with platelet counts < 50,000
- Active bleeding
- Need for therapeutic procedures during endoscopy
- Lactation
- Dysphagia, or other swallowing disorders
Show all 18Show fewer
- Known esophageal diverticulum or stricture
- Swallowing disorder
- Known luminal, gastrointestinal strictures
- Patient with Crohn's disease or other potential obstructive conditions, unless there is a recent Computed tomography enterography (CTE) or Magnetic resonance enterography (MRE), MRE or patency capsule performed to exclude an obstructive lesion that may retain the capsule
- History of esophageal, gastric surgery or intestinal surgery
- Esophageal or GI motility disorder
- Known or suspected gastrointestinal obstruction, significant intestinal strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
- Current participation in another investigational drug or device treatment study
- Pregnant or wishes to become pregnant during the study follow-up period
- Patient with implanted medical device that would be potentially affected radiofrequency emissions (e.g., pacemakers, implanted cardiac defibrillators)
- Severe psychiatric, neurological, cardio-vascular, or renal disorders
- History of allergy or intolerance to materials used to make the PillBot
About this study
Official title: Feasibility and Safety of PillBot™ - Remotely Controlled Capsule Endoscopy: A Feasibility Study
The PillBot System is an endoscopic capsule imaging system intended for visualization of the stomach. In contrast to currently used passive capsule endoscopy systems, and FDA cleared active magnetic system, the PillBot System uses active, motorized propulsion technology to facilitate the navigation and positioning of the capsule within the stomach anatomy for imaging of the gastric mucosa by an operator
- Conditions
- Gastric Disease
- Being tested
- PillBot
- Medical subject headings
- Stomach Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillBotDevice
The PillBot System uses active, motorized propulsion technology to facilitate the navigation and positioning of the capsule within the stomach anatomy for imaging of the gastric mucosa by an operator.
| Study group | Role | What they receive |
|---|---|---|
| PillBot | Experimental | Patient will swallow the PillBot and be assessed with EGD after two hours of the examination Receives: Device: PillBot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Adverse events rate during and following device use.
Measured: Up to two weeks
Primary Effectiveness Endpoint
Identification of the gastric anatomy landmarks (cardia, fundus, body, angulus, antrum, and pylorus) with PillBot compared to conventional endoscopy.
Measured: Through study completion, an average of two weeks
Secondary outcomes (2)
Secondary Study Endpoints
- Complete gastric examination using PillBot and its passage into the duodenum.
Complete gastric examination is defined as the ability to identify and distinguish lesion type (i.e., polyps, ulcers, submucosal humps, etc.), lesion size (e.g., <5mm and > 5mm) and location when using the PillBot compared with conventional endoscopy.
Measured: Through study completion, an average of two weeks
Secondary Study Endpoints
- Accuracy of gastric lesions detection by the RCE compared to the upper endoscopy based on independent reviewer's assessment.
Measured: Through study completion, an average of two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study startMay 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric DiseaseStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endiatx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212206
- Sponsor's protocol ID
- Endiatx
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of PillBot™ - Remotely Controlled Capsule Endoscopy: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06212206
- Acronym / sponsor ID
- Endiatx
- Conditions
- Gastric Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- EndiatxIndustry (pharma, biotech, devices)
- Study start
- May 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Jan 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.
The PillBot System is an endoscopic capsule imaging system intended for visualization of the stomach. In contrast to currently used passive capsule endoscopy systems, and FDA cleared active magnetic system, the PillBot System uses active, motorized propulsion technology to facilitate the navigation and positioning of the capsule within the stomach anatomy for imaging of the gastric mucosa by an operator
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PillBot | Experimental | Device: PillBotPatient will swallow the PillBot and be assessed with EGD after two hours of the examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Ability to provide written, informed consent to undergo both capsule endoscopy (un-sedated) and conventional OGD
- Willing and able to complete study follow-up requirements
- Patient has appropriate indications for upper endoscopy including symptoms of, but not limited to upper abdominal pain, acid reflux, heartburn, iron deficiency anemia, weight loss, bloating, belching, nausea, vomiting and atypical chest pain
Key exclusion criteria (18 listed)
- All patients who meet any of the following criteria should not be enrolled into the study:
- Coagulopathy with INR > 1.5, thrombocytopenia with platelet counts < 50,000
- Active bleeding
- Need for therapeutic procedures during endoscopy
- Lactation
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 |
|---|---|---|
| PillBotThe PillBot System uses active, motorized propulsion technology to facilitate the navigation and positioning of the capsule within the stomach anatomy for imaging of the gastric mucosa by an operator. | Device | PillBot |
Primary outcome
Primary Safety Endpoint
Time frame: Up to two weeks
Adverse events rate during and following device use.
Primary Effectiveness Endpoint
Time frame: Through study completion, an average of two weeks
Identification of the gastric anatomy landmarks (cardia, fundus, body, angulus, antrum, and pylorus) with PillBot compared to conventional endoscopy.
2 secondary outcomes
Secondary Study Endpoints
Time frame: Through study completion, an average of two weeks
Secondary Study Endpoints
Time frame: Through study completion, an average of two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PillBot in people with Gastric Disease, run by Endiatx.
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 4 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Primary Safety Endpoint (time frame: Up to two weeks). The study lists 2 primary outcomes in all. 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 18 Jan 2024.