PillSense for Suspected Upper Gastrointestinal Bleeding

NCT06500468 | Recruiting DMC FDA Device

• 1 other identifier: 2024/00060
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy and safety of a novel blood sensing capsule (PillSense), to help emergency doctors better evaluate if patients have active upper digestive tract bleeding, to determine if they can be discharged safely. The PillSense System consists of the PillSense Capsule, a small single use capsule that is safe for human consumption and PillSense Receiver, an external real-time monitor for data display to detect the presence of bleeding in the upper digestive tract within 10 minutes.

Conditions

Bleeding Ugi

Keywords

capsule endoscopy; upper gastrointestinal bleeding; melena; coffee ground vomitting; emergency department; triage

Outcome Measures

Primary Outcomes (1)

• Discharge rate of patients with stable UGIB who can be triaged home safely after ED visit

  To compare the percentage of patients who are safely discharged from ED visit with the usage of PillSense, compared to standard treatment.

  1.5 years

Secondary Outcomes (5)

• Risk of clinical rebleeding after a negative PillSense reading

  1.5 years

• Discharge rate of patients who can be triaged home using PillSense , compared to conventional clinical scoring system like Glasgow Blatchford Score (GBS).

  1.5 years

• Number of inpatient beds saved from this arrangement

  1.5 years

• Risk of patient morbidity after a negative PillSense reading

  1.5 years

• Risk of patient mortality after a negative PillSense reading

  1.5 years

Study Arms (2)

PillSense group

EXPERIMENTAL

Participants in the PillSense arm will swallow one PillSense capsule. Participants who have blood detected will be admitted with a scheduled oesophagogastroduodenoscopy within 72 hours. Participants with no blood detected will be discharged with medications and a scheduled OGD within 96 hours.

Device: PillSense System

Standard group

NO INTERVENTION

Participants randomized to the standard arm will follow standard of care and will either be admitted or discharged with medications and to undergo an oesophagogastroduodenoscopy (OGD) within 72 hours if admitted or 96 hours if discharged.

Interventions

PillSense System DEVICE

The PillSense System consists of the PillSense Capsule, a small single use capsule that is safe for human consumption and PillSense Receiver, an external real-time monitor for data display. The PillSense Capsule is a minimally invasive, single use medical device designed to detect the presence of bleeding in the upper digestive tract, to aid with patient care. The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule within 10 minutes. The PillSense Receiver interprets the data and displays a result message "Blood detected" or "No blood detected".

PillSense group

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 21 years and above and are able to give consent.
• Patients who are willing and able to comply with the study protocol (including undergoing endoscopy)
• Presented to Emergency Department with symptoms of acute overt upper gastrointestinal bleeding such as coffee ground vomiting and melena (but without melaena on physical examination)

You may not qualify if:

• Patients who had hemodynamic shock (systolic blood pressure below 90 mm Hg and pulse rate over 120/min)
• Patients who presented with fresh hematemesis, hematochezia and/or melaena
• Patients requiring urgent endoscopy / surgery at time of review or already planned for admission by ED physician for non UGIB related indications
• Patients who had conditions that might contraindicate the use of an ingestible capsule, such as capsule endoscopy (eg. Dysphagia, odynophagia, swallowing disorder, and/or Zenker's diverticulum, issues with the motility of the gastrointestinal tract, Crohn's disease, previous GI surgery, suspected ileus, bowel obstruction and/or perforation)
• Patients with a known history of oesophageal or gastric varices
• Patients with known UGI pathology (such as oesophageal/gastric cancer), or recent (within 3 months) upper GI ulcer bleeding, upper GI surgeries or procedures
• Patients who are on anticoagulation
• Patients with cardiac implantable electrical device (CIED)
• Patients who had altered mental status
• Pregnant and/or lactating women (Female patients below age 60, without history of hysterectomy or are not documented to be post-menopausal, will be given a urine pregnancy test to confirm they are not pregnant)
• Patients who have an MRI investigation planned within 2 weeks

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• EnteraSense Limited: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Melena; Emergencies

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr Ng Wee Khoon

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Ng Wee Khoon

CONTACT

+65 8938 1462; wee_khoon_ng@ttsh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: Partipants will be randomised into either of the 2 arms: PillSense Group (Treatment arm) or Standard group (where they will receive standard of care) for the duration of the study.

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 15, 2024
• Study Start: July 18, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)