Clinical trial NCT06212206: PillBot™ - Remotely Controlled Capsule Endoscopy
Official title: Feasibility and Safety of PillBot™ - Remotely Controlled Capsule Endoscopy: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastric Disease
Lead sponsor: Endiatx
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 the capsule within the stomach anatomy for imaging of the gastric mucosa by an operator


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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
* 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

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: Up to two weeks
measure: Primary Effectiveness Endpoint
timeFrame: Through study completion, an average of two weeks
Secondary outcomes:
measure: Secondary Study Endpoints
timeFrame: Through study completion, an average of two weeks
measure: Secondary Study Endpoints
timeFrame: Through study completion, an average of two weeks
Other outcomes:
Locations:
Study officials:
References: