N/A
N=30
Detection of Upper Gastrointestinal (GI) Bleeding With a Novel Bleeding Sensor Capsule [DING]
Upper GI Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT03176407 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With (Serious) Adverse Event Related to the Medical Device — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HemoPill acute (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ovesco Endoscopy AG
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With (Serious) Adverse Event Related to the Medical Device |
— | — |
| PRIMARY Number of Participants With Device Deficiencies |
— | — |
| PRIMARY Number of Participants With Human Failures in Capsule Application |
1 | — |
| PRIMARY Number of Participants With Sensor Capsule Ingestion Problems |
— | — |
| PRIMARY Number of Patients Which do Not Accept the Medical Device, Measured in Numbers |
— | — |
Summary
The clinical trial entitled "Detection of upper gastrointestinal (GI) bleeding with a novel bleeding sensor capsule - a pilot study" was carried out in a monocentric clinical trial with 30 patients. This trial aimed to determine if the capsule's sensor signals allow to deduct the patient's bleeding status in a clinical setting.
The target of the explorative study was to show the feasibility and safety of the HemoPill acute and its implementation procedure as well as, the definition of measurable parameters and thresholds for blood detection. Within this clinical trial, initial clinical data on the performance of the HemoPill acute capsule were collected.
Eligibility Criteria
Inclusion Criteria
- clinical suspicion based on anamnestic statements and clinical symptom
- vomiting of hematin (coffee-ground-like material)
- hematemesis
- melena (anamnestic or digital rectal evidence)
- attentive and conscious patient
- written informed consent, age ≥ 18 years and ≤ 80 years
Exclusion Criteria
- circulatory instability (with a clear need for urgent endoscopy)
- cases which required urgently surgical therapy, e.g. patients previously treated endoscopically because of GI bleeding and with an urgent suspicion of recurrent bleeding, which could not be treated endoscopically because of previous findings as well as patients experiencing re-bleeding after surgery
- known and assumed stenosis of the GI tract, e.g. patients with fistulas, malformations and anatomical variability, insufficiencies, adhesions and previous traumas
- pacemakers or other implantable electrical devices
- difficulties in swallowing pills the size of the capsule known dysphagia (e.g. achalasia, known diverticula of the esophagus etc.) which were inoperable: patients with ASA IV or higher
- known and distinct retardation of the gastro-intestinal tract, induced by previous surgeries, stenosis or paralytic ileus with a diagnosed enteritis
- moribund patient
- pregnancy and breastfeeding
- psychological illnesses, which might impair patient cooperation (comprehension problems, informed consent impossible)
- stomach bezoar
- NSAR-induced enteropathy
- known allergies against Parylene (surface coating of the capsule)
- peptic esophagitis III an IV
- florid M.Crohn or known inflammation-induced strictures
- distinct diverticulosis or diverticulitis
- suspected gastrointestinal tumor disease
- necessity of MRI investigation
- heavy genetic bleeding tendency (e.g. factor VIII deficiency)
- esophagus varices
- class III obesity (BMI ≥ 40)
- missing informed consent
- age 80 years
Data sourced from ClinicalTrials.gov (NCT03176407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.