NCT05899491

Brief Summary

To study the role of a novel endoscopic treatment technique (ARMA) in GERD patients who doesn't respond to PPI therapy (Proton Pump Inhibitor).

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 Mar 2023

Shorter than P25 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

Study Start

First participant enrolled

March 30, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

April 4, 2025

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

April 1, 2023

Last Update Submit

April 2, 2025

Conditions

GERDRefluxReflux Esophagitis

Outcome Measures

Primary Outcomes (1)

  • Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months.

    Improvement in Gastroesophageal reflux disease symptoms by more than 50% from baseline at 3 months which would be assessed based on visual analog scale VAS 0 LOW SCORE 10 WORSE SYMPTOM SCORE.

    One Year

Secondary Outcomes (1)

  • Improvement in esophageal acid exposure

    One Year

Study Arms (2)

ARMA Group

ACTIVE COMPARATOR

All patients in this group will undergo Anti-reflux mucosal ablation using upper gastrointestinal endoscopy. The stomach will be insufflated with CO2 to visualize the cardia in retroflex view.

Procedure: ARMA

Sham Group

SHAM COMPARATOR

UGI Endoscopy will be performed under Propofol based sedation with scope kept inside for at least 5 minutes.

Procedure: UGI Endoscopy

Interventions

ARMAPROCEDURE

Patients will be instructed to fast for 6 hours pre-ARMA, the Procedure will be performed under propofol-based sedation. Patients will be in the left lateral decubitus position. The stomach will be insufflated with CO2 to visualize the cardia in retroflex view.

ARMA Group
UGI EndoscopyPROCEDURE

UGI Endoscopy will be performed under propofol based sedation with scope kept inside for atleast 5 minutes. Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry, reflux questionnaire.

Sham Group

Eligibility Criteria

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

You may qualify if:

  • Normal Upper Gastrointestinal endoscopy And
  • hour pH Impedance: AET \< 6%, More than 80 refluxes
  • Patients who are willing to give consent for the procedure

You may not qualify if:

  • Large Hiatal hernia \>3cm
  • Lower esophageal sphincter (LES) pressure \>15 mm Hg
  • Paraesophageal hernia
  • GE flap valve grade IV (Hill's classification)
  • Barretts esophagus
  • Esophageal dysmotility
  • ASA physical status \>II
  • Previous esophageal or gastric surgery
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian institute of Gastroenterology, hyderabad, India

Hyderabad, Telangana, 500032, India

Location

Related Publications (3)

  • Inoue H, Tanabe M, de Santiago ER, Abad MRA, Shimamura Y, Fujiyoshi Y, Ueno A, Sumi K, Tomida H, Iwaya Y, Ikeda H, Onimaru M. Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study. Endosc Int Open. 2020 Feb;8(2):E133-E138. doi: 10.1055/a-1031-9436. Epub 2020 Jan 22.

    PMID: 32010745BACKGROUND

  • Chou CK, Chen CC, Chen CC, Wu JF, Liao WC, Chiu HM, Wang HP, Wu MS, Tseng PH. Positive and negative impact of anti-reflux mucosal intervention on gastroesophageal reflux disease. Surg Endosc. 2023 Feb;37(2):1060-1069. doi: 10.1007/s00464-022-09605-z. Epub 2022 Sep 15.

    PMID: 36109362BACKGROUND

  • Rodriguez de Santiago E, Albeniz E, Estremera-Arevalo F, Teruel Sanchez-Vegazo C, Lorenzo-Zuniga V. Endoscopic anti-reflux therapy for gastroesophageal reflux disease. World J Gastroenterol. 2021 Oct 21;27(39):6601-6614. doi: 10.3748/wjg.v27.i39.6601.

    PMID: 34754155BACKGROUND

MeSH Terms

Conditions

Gastroesophageal RefluxEsophagitis, Peptic

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesEsophagitisGastroenteritisPeptic UlcerDuodenal DiseasesIntestinal DiseasesStomach Diseases

Study Officials

  • Neeraj Singla, MD

    Asian Institute of Gastroenterology, Hyderabad

    PRINCIPAL INVESTIGATOR

  • Digvijay Chavan

    Asian Institute of Gastroenterology, Hyderabad

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
A Randomized Sham Control Trial
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: A Randomized Sham Control Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2023

First Posted

June 12, 2023

Study Start

March 30, 2023

Primary Completion

September 30, 2023

Study Completion

December 30, 2023

Last Updated

April 4, 2025

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)