An interventional study of PillBot in Gastric Disease, sponsored by Endiatx. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by Endiatx · Not applicable, Interventional, and Diagnostic
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
53 studies on the registry are indexed under Stomach Diseases; 6 are open to participants now.
This study's planned enrollment of 20 is below the median of 75 across 39 interventional studies indexed under Stomach Diseases.
Browse Stomach Diseases studies →This is the only study on the registry with Endiatx as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All patients who meet any of the following criteria should not be enrolled into the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient will swallow the PillBot and be assessed with EGD after two hours of the examination
Device: PillBot
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.
Primary Safety Endpoint
Adverse events rate during and following device use.
Time frame: 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.
Time frame: Through study completion, an average of two weeks
Secondary Study Endpoints
1. 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.
Time frame: Through study completion, an average of two weeks
Secondary Study Endpoints
2. Accuracy of gastric lesions detection by the RCE compared to the upper endoscopy based on independent reviewer's assessment.
Time frame: Through study completion, an average of two weeks
No study locations are listed for this record.
Start is estimated for May 2024; primary completion for Dec 2024, 7 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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