NCT03240679

Brief Summary

This study is being done to test the usefulness of extracellular matrix (ECM) a thin sheet placed over the site after endoscopic mucosal resection to promote healing of the esophagus.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

March 22, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

February 6, 2023

Completed
Last Updated

February 6, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

April 5, 2017

Results QC Date

January 10, 2023

Last Update Submit

January 10, 2023

Conditions

Barretts Esophagus With High Grade DysplasiaBarrett Adenocarcinoma

Keywords

Barrett's esophagusEndoscopic Mucosal Resection

Outcome Measures

Primary Outcomes (1)

  • Completeness of EMR Site Healing at Follow up Endoscopy

    Number of subjects to have complete endoscopic submucosal resection (EMR) site healing determined by the ability of the resection site to lift with saline injection during follow-up endoscopy.

    approximately 3-4 months post EMR

Secondary Outcomes (1)

  • Presence of Stricture Formation at Follow up Endoscopy

    approximately 3-4 months post EMR

Study Arms (2)

Endoscopic submucosal resection with Extracelluar Matrix

ACTIVE COMPARATOR

Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.

Device: Acell MatriStem® Surgical Matrix

Endoscopic submucosal resection standard of care

NO INTERVENTION

Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.

Interventions

Acell MatriStem® Surgical MatrixDEVICE

Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.

Endoscopic submucosal resection with Extracelluar Matrix

Eligibility Criteria

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

You may qualify if:

  • Able to provide consent
  • Scheduled for standard of care endoscopy that may require initial EMR evaluation of esophageal lesions
  • Histological evidence of intestinal metaplasia with dysplasia or intramucosal carcinoma

You may not qualify if:

  • Pregnant women
  • Prior esophageal EMR or ESD in the same region
  • Anyone unable to provide informed consent
  • Medical co-morbidities precluding EGD evaluation
  • History of chemoradiotherapy to the neck/esophagus
  • Unable to stop anticoagulation therapy (non-steroid anti-inflammatory medications are permissible)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Limitations and Caveats

Study terminated due to difficulty of obtaining investigational product and study support. Only 3 subjects accrued into the study who underwent initial endoscopy with treatment and follow-up endoscopies approximately 3 months later.

Results Point of Contact

Title
Dr. Kenneth K. Wang
Organization
Mayo Clinic
wang.kenneth@mayo.edu
507-284-2691

Study Officials

  • Kenneth K Wang

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Pilot study 10 in each group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pricipal Investigator

Study Record Dates

First Submitted

April 5, 2017

First Posted

August 7, 2017

Study Start

March 22, 2017

Primary Completion

June 20, 2017

Study Completion

June 20, 2017

Last Updated

February 6, 2023

Results First Posted

February 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)