NCT04516460

Brief Summary

A Prospective Interventional Multicentric Study to Evaluate Effectiveness and Safety of PuraStat in the Management of delayed bleeding following Endoscopic Mucosal Resection (EMR) in the colon and rectum.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 28, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 28, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2022

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

1.5 years

First QC Date

July 28, 2020

Last Update Submit

August 15, 2020

Conditions

Bleeding After Resection of Colorectal Neoplastic Lesions

Outcome Measures

Primary Outcomes (1)

  • Clinically relevant delayed bleeding rate

    (as defined above)

    1 month after procedure

Secondary Outcomes (3)

  • Technical feasibility of PuraStat application to the desired site

    1 day

  • Duration of application of PuraStat

    1 day

  • Occurrence of Suspected Unexpected Serious Adverse Reactions (SUSAR) related to PuraStat

    1 day

Study Arms (1)

PuraStat

EXPERIMENTAL

Interventional arm: PuraStat® applied through a catheter delivery system via the endoscope is used to prevent bleeding after endoscopic resection

Device: Interventional arm: endoscopic resection plus PuraStat®

Interventions

Interventional arm: endoscopic resection plus PuraStat®DEVICE

Interventional arm: PuraStat® applied through a catheter delivery system via the endoscope is used to prevent bleeding after endoscopic resection of colorectal neoplastic lesions

PuraStat

Eligibility Criteria

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

You may qualify if:

  • All of the following:
  • Presence of 1 lesion \>2cm in the colon or rectum
  • Patients able to give informed consent.
  • Patients over 18 years of age.

You may not qualify if:

  • ANY of the following:
  • resection of more than one large (≥20mm) polyp
  • ulcerated lesion (Paris III morphology)
  • lesions with invasive component
  • inflammatory bowel disease
  • poor health condition (American Society of Anesthesiologists class IV) resection by -endoscopic submucosal dissection
  • incomplete EMR
  • use of clips in the mucosal defect
  • previous attempts of endoscopic resection of the same lesion suspected deep damage in the muscularis propria
  • coagulation disorder (international normalized ratio \>1.5, platelets \<50) pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Pedro Hispano

Matosinhos Municipality, Portugal

RECRUITING

Study Officials

  • Masami Omae, MD

    Karolinska Hospital

    STUDY CHAIR

Central Study Contacts

Francisco Baldaque Silva, MD PhD

CONTACT

+46704997219fbaldaquesilva@gmail.com

Jose Soares, MD

CONTACT

jmmgso@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 18, 2020

Study Start

July 28, 2020

Primary Completion

January 28, 2022

Study Completion

January 28, 2022

Last Updated

August 18, 2020

Record last verified: 2020-08

Locations

PT(1)