HemoPill Acute ® in Suspected Nonvariceal Upper Gastrointestinal Bleeding

NCT04472364 | Completed

• 2 other identifiers: Brand_HemoPill_07_07_2020U1111-1254-9251
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 4

Brief Summary

The study examines, whether the use of the HemoPill Acute ® capsule in case of suspected nonvariceal upper gastrointestinal bleeding can identify cases in which endoscopy can be delayed to 48-96 hours without risk to the patient.

Conditions

Upper Gastrointestinal Bleeding

Keywords

Upper Gastrointestinal Bleeding; Capsule endoscopy; Emergency endoscopy

Outcome Measures

Primary Outcomes (1)

• Rate of avoided emergency endoscopies (usually done within 24 hours) in case of negative HemoPill.

  In how many cases with a negative HaemoPill, the endoscopy interval can be extended to at least 48 hours without acute re-bleeding (confirmed in unscheduled emergency endoscopy) occurring in the meantime. The criteria for suspected re-bleeding (leading to an unscheduled emergency endoscopy) are: Hematemesis, again melena or hematochezia after normalized stool, tachycardia (≥110 / min) or hypotension (RRsys ≤90 mm Hg) without other explanation, decrease in the Hb value ≥2 g/dl in the course without other explanation (e.g. dilution, nosebleeds ), no increase in Hb after transfusion of erythrocyte concentrate (s) (measured after 24 hours).

  48 to 96 hours after swallow the capsule

Secondary Outcomes (4)

• Rate of true positive HemoPill results leading to an emergency endoscopic intervention

  12 hours after swallow the capsule

• Rate of false positive HemoPill results

  12 hours after swallow the capsule

• Rate of false negative HemoPill results

  48 to 96 hours after swallow the capsule

• The use of the HemoPill Acute ® capsule as part of emergency care is safe and technically easy.

  30 Days after discharge

Study Arms (1)

HemoPill

EXPERIMENTAL

All participants will receive the blood detection capsule HemoPill Acute ®.

Device: HemoPill Acute ®

Interventions

HemoPill Acute ® DEVICE

Capsule positive: Endoscopy endoscopy will be performed within 12 hours. Capsule negative: Endoscopy will be performed after 48 to 96 hours.

HemoPill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Emergency presentation with clinical suspicion of non-variceal upper GI bleeding (e.g. haematin vomiting, melena, etc.)
• hemodynamic stable patient (heart rate \<100 / min, Blood pressure sys ≥ 100mmHg)
• Emergency endoscopy indicated (modified Glasgow-Blatchford-Score ≥ 2 points)
• Administration of proton pump inhibitors possible (no allergy known)
• Good communication (without translator) with the study doctor and fulfill all requirements of the study
• Written consent after detailed information about the study

You may not qualify if:

• Hemodynamically unstable patients (HF\> 100 / min, RR \<100mmHg despite fluid administration) with indication for endoscopy within 12 hours
• Indication for endoscopy within 12 hours recommended by endoscopy call service
• Clinical suspicion of variceal bleeding of the upper GI tract (risk factors according to german guidelines: cirrhosis of the liver, splanchnic thrombosis, thrombocytopenia, known increased liver / spleen stiffness, known esophageal varices)
• Clinical suspicion of lower GI bleeding (e.g. hematochezia)
• Vomiting blood (hematemesis observed by the emergency doctor or in the clinic)
• Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis)
• Severe acute and chronic organ diseases that need treatment (e.g. kidney replacement treatment) (ASA ≥4)
• Changed anatomy of the upper GI tract (e.g. gastric resection)
• Known or suspected gastrointestinal obstructions, strictures, fistulas or known diverticula
• Dysphagia or other swallowing disorders
• Awareness restrictions that make it impossible to swallow the HemoPill Acute ® capsule on your own
• Patients with pacemakers, defibrillators, or other implantable electromedical devices
• Known allergy to parylene (capsule surface)
• Soon MRI scan planned
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• Vivantes Netzwerk für Gesundheit GmbH: collaborator
• University Hospital Freiburg: collaborator
• Sana Klinikum Offenbach: collaborator

Study Sites (4)

Klinikum Friedrichshain

Berlin, 10249, Germany

Location

Universitästklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Sana Klinikum Offenbach GmbH

Offenbach, 63069, Germany

Location

Universitätsklinik Würzburg

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Meining, Prof. Dr.

  Universital Hospital Würzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician - Gastroenterologist

Model Details: All participants will receive the HemoPill Acute ® capsule. In case of blood detection in the upper gi-tract (capsule positive), the endoscopy will be performed within 12 hours. If no blood is found in the upper GI tract (capsule negative), endoscopy will be performed after 48 to 96 hours.

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 15, 2020
• Study Start: October 8, 2020
• Primary Completion: April 8, 2024
• Study Completion: April 8, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)