NCT05385224

Brief Summary

This is a prospective, non-randomized, open-label clinical investigation to evaluate feasibility, effectiveness and safety of the PillSense System, the transit of the PillSense Capsule through the GI tract, patient tolerability of the PillSense Capsule, and blood detection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 26, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

March 22, 2022

Results QC Date

September 7, 2023

Last Update Submit

October 2, 2023

Conditions

UGI BleedUpper Gastrointestinal BleedingUpper Gastrointestinal Bleed

Keywords

EnteraSensePillSenseUGI BleedUGIBUpper Gastrointestinal BleedingUpper Gastrointestinal BleedUpper Gastrointestinal

Outcome Measures

Primary Outcomes (2)

  • Sensitivity

    To assess the sensitivity of the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either "Blood detected" or "No blood detected". Sensitivity = True Positives / (True Positives + False Negative). True positives were observations of bleed detected via PillSense capsule confirmed via esophagogastroduodenoscopy (EGD)\]. False negatives were observation of bleed not detected via capsule but EGD confirmed bleed.

    Day 1

  • Specificity

    To evaluate the specificity of the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either "Blood detected" or "No blood detected". Specificity=True Negatives / (True Negatives + False Positive). True negatives were observations of no bleed detected via PillSense capsule confirmed via esophagogastroduodenoscopy (EGD)\]. False positives were observation of bleed detected via capsule but EGD confirmed no bleed.

    Day 1

Secondary Outcomes (3)

  • NPV

    Day 1

  • Transit

    Day 1 through Day 14

  • PPV

    Day 1

Study Arms (1)

PillSense (Active)

EXPERIMENTAL

This is a single-arm, non-randomized study.

Diagnostic Test: PillSense

Interventions

PillSenseDIAGNOSTIC_TEST

The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.

PillSense (Active)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>=18 years
  • Ability to provide informed consent
  • Clinical suspicion of UGIB

You may not qualify if:

  • Circulatory or hemodynamic instability
  • Known GI tract stricture
  • Using an implantable electrical device
  • Difficulties in swallowing pills the size of the capsule
  • History of: achalasia or known esophageal dysmotility; gastroparesis; severe constipation; Crohn's disease; bowel obstruction
  • Currently taking medications intended for stimulation of GI motility
  • Currently pregnant or breastfeeding, or intend to become pregnant during the investigation
  • Suspected or previously diagnosed obstructing gastrointestinal tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Akiki K, Mahmoud T, Alqaisieh MH, Sayegh LN, Lescalleet KE, Abu Dayyeh BK, Wong Kee Song LM, Larson MV, Bruining DH, Coelho-Prabhu N, Buttar NS, Sedlack RE, Chandrasekhara V, Leggett CL, Law RJ, Rajan E, Gleeson FC, Alexander JA, Storm AC. A novel blood-sensing capsule for rapid detection of upper GI bleeding: a prospective clinical trial. Gastrointest Endosc. 2024 May;99(5):712-720. doi: 10.1016/j.gie.2023.11.051. Epub 2023 Dec 6.

    PMID: 38065512DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
David Collins, Director of Technical Operations
Organization
EnteraSense Ltd.
david@enterasense.com
091 750 246

Study Officials

  • David Collins

    Technical Operations Director

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2022

First Posted

May 23, 2022

Study Start

December 10, 2021

Primary Completion

September 7, 2022

Study Completion

September 13, 2022

Last Updated

October 26, 2023

Results First Posted

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)