NCT03955055

Study of Early Endocapsule (EC) in Clinical Decision Unit Versus Standard of Care Work-up for GI Bleeding

Completed NA Results posted Last updated 10 July 2023

What this trial tests

NA trial testing Video Capsule Endoscopy in Gastro Intestinal Bleeding in 35 participants. Completed in 9 April 2022.

Timeline

4 February 2020

Primary endpoint
9 April 2022

9 April 2022

Quick facts

Lead sponsor	Christopher Marshall
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	35
Start date	4 February 2020
Primary completion	9 April 2022
Estimated completion	9 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Video Capsule Endoscopy

Conditions studied

• Gastro Intestinal Bleeding — all drugs for Gastro Intestinal Bleeding →
• Hematemesis — all drugs for Hematemesis →
• Melena — all drugs for Melena →

Sponsor

Christopher Marshall

Who can join

18 and older, any sex, with Gastro Intestinal Bleeding or Hematemesis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rate of Detection of Bleeding Primary · Enrollment to time of detection of bleeding as measured in hours, up to 720 hours, whichever is sooner

Rate of detection of active bleeding or stigmata of recent bleeding \[blood clot or visible vessel\]

Group	Value	95% CI
Early Capsule Group	11
Standard of Care Work-up	11

Time to Detection of Bleeding Primary · Enrollment to time of detection of bleeding as measured in hours, up to 720 hours, whichever is sooner

Time to detection of active bleeding or stigmata of recent bleeding \[blood clot or visible vessel\]

Group	Value	95% CI
Early Capsule Group	20.9	± 1.9
Standard of Care Work-up	17.7	± 9.5

Admission Rate Secondary · Enrollment to time of admission as measured in hours, up to 720 hours, whichever is sooner

Rate of in-patient admissions to the hospital

Group	Value	95% CI
Early Capsule Group	14
Standard of Care Work-up	20

Re-admission Rate Secondary · Enrollment to 720 hours

Rate of in-patient re-admissions to the hospital

Group	Value	95% CI
Early Capsule Group	4
Standard of Care Work-up	2

Hospital Length of Stay Secondary · Enrollment to time of discharge as measured in hours, up to 720 hours, whichever is sooner

Length of hospital stay measured in hours

Group	Value	95% CI
Early Capsule Group	143.7	± 102.3
Standard of Care Work-up	140.9	± 80.5

Endoscopic Procedures Secondary · Enrollment to 720 hours

Number of endoscopic procedures performed

Group	Value	95% CI
Early Capsule Group	1.9	± 0.66
Standard of Care Work-up	1.35	± 0.67

Therapeutic Procedures Secondary · Enrollment to 720 hours

Number of therapeutic procedures performed

Group	Value	95% CI
Early Capsule Group	0.29	± 0.47
Standard of Care Work-up	0.35	± 0.59

Complication Rates Secondary · Enrollment to 720 hours

Percentage of participants who experienced a complication.

Group	Value	95% CI
Early Capsule Group	6
Standard of Care Work-up	4

Blood Product Transfusions Secondary · Enrollment to one year

Number of blood products transfused

Group	Value	95% CI
Early Capsule Group	1.8	± 1.6
Standard of Care Work-up	2.2	± 2.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Early Capsule Group

Serious: 4/14 (29%)

Deaths: 0/14

Standard of Care Work-up

Serious: 3/20 (15%)

Deaths: 2/20

Serious adverse events (6 terms)

Reaction	System	Early Capsule Group	Standard of Care Work-up
Melena	Gastrointestinal disorders	—	—
Shortness of breath	Respiratory, thoracic and mediastinal disorders	—	—
Gastrointestinal Bleeding	Gastrointestinal disorders	—	—
Hypoxemia	Cardiac disorders	—	—
Acute allergic reaction	Immune system disorders	—	—
Coronavirus	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Early Capsule Group	Standard of Care Work-up
Capsule retention	Gastrointestinal disorders	—	—

Most-reported serious reactions: Melena, Shortness of breath, Gastrointestinal Bleeding, Hypoxemia, Acute allergic reaction, Coronavirus.

Data from ClinicalTrials.gov NCT03955055 adverse events section.

Sponsor's own description

This study will evaluate the use of the Olympus EndoCapsule EC-10 video capsule compared with the standard of care workup for patients in the Clinical Decision Unit who have symptoms of gastrointestinal (GI) bleeding. Patients will be eligible if they have any symptoms of GI bleeding, either vomiting blood or symptoms without vomiting blood.

Patients randomized to the early capsule arm will have an immediate video capsule endoscopy. Patients randomized to the standard of care arm will have no study intervention and will follow the treating physician's diagnostic workup.

The primary goal of the study is to compare how often a source of bleeding is identified in patients in the two groups.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.