Detection of Upper Gastrointestinal (GI) Bleeding With a Novel Bleeding Sensor Capsule [DING]
Condition: Upper GI Bleeding
MeSH terms: Hemorrhage
Study type: Interventional

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.
    

Detailed description: 
      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 as part of the final development phase of the HemoPill acute, a bleeding sensor
      capsule. The swallowable capsule operates with the combination of an optical sensor for blood
      detection positioned within a recess in the capsule surface and a radio interface for
      wireless transmission of sensor data to an external receiver device. The HemoPill acute
      capsule is used for diagnosis of patients with suspected acute upper gastrointestinal
      bleeding.

      For the study, the HemoPill acute capsule was swallowed by the patient and a special
      extracorporeal receiver was positioned next to the patient's body. The receiver recorded
      sensor signals from the ingested capsule for the next 4 hours. Patients who had swallowed a
      capsule underwent endoscopy within the next 12 hours. Later, both the endoscopic pictures and
      the endoscopy report were compared to the sensor capsule data recorded in the extracorporeal
      receiver. Furthermore, the excretion of each HemoPill acute capsule was monitored in
      accordance with the study protocol (regular check to see if sensor signal was still
      detectable from inside the patient's body) for a follow-up period of 10 days.
    

Intervention name(s): HemoPill acute
Intervention type(s): Diagnostic Test
Intervention description(s): Capsule is swallowed by the patient and an external study receiver records the capsule sensor data for 4 consecutive hours. Patients undergo endoscopy within 12 hours after capsule ingestion. Afterwards, the endoscopic findings (endoscopy pictures and patient's endoscopy report) are compared to the sensor capsule data results. Capsule excretion is monitored for up to 4 days. If excretion is not recorded during that time, a follow-up examination of the patient is conducted after 10 days.
Intervention model: Single Group Assignment
Intervention model description: There is only one patient group. The one that swallow the sensor capsule.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: sensor capsule