NCT06939907

Brief Summary

Clinical Trial to Evaluate the Efficacy and Safety of Nexpowder™ for Diverticular Bleeding in the Lower Gastrointestinal Tract

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
not yet recruiting

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 Progress45%
Jun 2025Jul 2027

First Submitted

Initial submission to the registry

April 11, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 23, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

April 11, 2025

Last Update Submit

April 24, 2025

Conditions

Lower Gastrointestinal BleedingDiverticular Bleeding

Outcome Measures

Primary Outcomes (1)

  • Rebleeding rate

    30 days after successful endoscopic hemostasis

    30 days post treatment

Secondary Outcomes (2)

  • Hemostasis rate

    Immediately after the procedure

  • Rebleeding rate

    7 days post treatment

Study Arms (1)

Nexpowder Treatment Arm

EXPERIMENTAL
Device: Nexpowder™

Interventions

Nexpowder™DEVICE

Nexpowder™ hemostatic powder

Nexpowder Treatment Arm

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 19 years or older at the time of screening
  • Patients diagnosed with diverticular bleeding

You may not qualify if:

  • Patients diagnosed with upper gastrointestinal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Chosun University Hospital

Gwangju, South Korea

Location

Sejong Chungnam National University Hospital

Sejong, South Korea

Location

Kangdong Kyunghee University Hospital

Seoul, South Korea

Location

Yangsan Busan National University Hospital

Yangsan, South Korea

Location

MeSH Terms

Conditions

Diverticular Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System Diseases

Study Design

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

Study Record Dates

First Submitted

April 11, 2025

First Posted

April 23, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

April 25, 2025

Record last verified: 2025-04

Locations

KR(6)