NCT04348266

Brief Summary

Use radiofrequency ablation (RFA) for Gastric intestinal metaplasia (GIM) treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration 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

First Submitted

Initial submission to the registry

April 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

2.7 years

First QC Date

April 12, 2020

Last Update Submit

July 29, 2023

Conditions

Gastric Intestinal MetaplasiaTreatmentRadio-frequency Ablation

Outcome Measures

Primary Outcomes (1)

  • Number of GIM lesions regression

    Regression of GIM lesions after RFA treatment compared to no treatment

    1 year

Secondary Outcomes (1)

  • Number of GIM regression by location

    1 year

Study Arms (2)

RFA

EXPERIMENTAL

The assigned location will be treated with RFA at all lesion.

Device: Radiofrequency ablation (RFA)

Control

NO INTERVENTION

No treatment will not be performed at this location. However, if endoscopist detects any suspicious lesion during the scheduled endoscopy, the biopsy will be done and standard treatment will be performed accordingly.

Interventions

Radiofrequency ablation (RFA)DEVICE

Radiofrequency ablation is a device that can generate the heat from radiofrequency for tissue ablation. RFA is a standard treatment for Barrett' esophagus and high grade dysplasia in esophagus.

RFA

Eligibility Criteria

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

You may qualify if:

  • More than 18 years of age
  • Previous diagnose of extensive or incomplete GIM

You may not qualify if:

  • No GIM at first endoscopy
  • Previous gastric surgery
  • Coagulopathy
  • Pregnancy or lactation
  • Unable to perform appropriate peri-procedural cessation of antiplatelet/antithrombotic therapy
  • Unable to sign the consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rapat Pittayanon

Pathum Wan, Bangkok, 10330, Thailand

Location

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The endoscopist who do the final endoscopy for assessing the efficacy of RFA will be blinded to the previous assigned location of RFA treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study in only GIM patients but will divide the stomach into 2 sites (left and right) to random for RFA treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

April 12, 2020

First Posted

April 16, 2020

Study Start

June 1, 2020

Primary Completion

February 28, 2023

Study Completion

May 31, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Do not share IPD to other researchers

Locations

TH(1)