Comparing Two Different Methods of Ablation of Inlet Patches (APC vs RFA)

NCT07252180 | Active Not Recruiting DMC

• 1 other identifier: 0190-25-ASF
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective study is to compare 2 different treatment options for the ablation of inlet patches in patients with esophageal symptoms. The main questions it aims to answer are: Is 1 method more effective than the other? Do patients prefer 1 method over the other? Participants will undergo ablation with either argon plasma or radiofrequency.

Conditions

GERD (Gastroesophageal Reflux Disease); Throat Disorders

Keywords

inlet patch; GERD

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  The main outcome will be the patient satisfaction score assessed five days after the initial ablation. This score will be on a 0-10 scale where 0 represents a horrible experience and 10 represents a wonderful experience. This score will be compared between the two groups.

  5 days after intervention

Secondary Outcomes (2)

• Procedures to eradication

  1 month after interventions

• Improvement in symptoms

  1 month after interventions

Study Arms (2)

APC

ACTIVE COMPARATOR

Argon plasma coagulation (APC) will be used to ablate the inlet patch

Procedure: Argon plasma coagulation (APC)

RFA

ACTIVE COMPARATOR

Radio frequency ablation (RFA) will be used to ablate the inlet patch

Procedure: RFA

Interventions

RFA PROCEDURE

Patients with have the inlet patch treated by RFA

RFA

Argon plasma coagulation (APC) PROCEDURE

During upper endoscopy, the inlet patches with be ablated. One arm with undergo APC ablation while the other arm will undergo RFA ablation.

APC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inlet patch \>5 mm in size
• Esophageal or throat symptoms
• Willing to participate

You may not qualify if:

• No inlet patch
• Unwilling to participate

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Shamir Medical Center

Ẕerifin, Israel

Location

Related Publications (3)

• Rusu R, Ishaq S, Wong T, Dunn JM. Cervical inlet patch: new insights into diagnosis and endoscopic therapy. Frontline Gastroenterol. 2018 Jul;9(3):214-220. doi: 10.1136/flgastro-2017-100855. Epub 2017 Nov 9.

  PMID: 30046427 BACKGROUND

• Chong VH. Clinical significance of heterotopic gastric mucosal patch of the proximal esophagus. World J Gastroenterol. 2013 Jan 21;19(3):331-8. doi: 10.3748/wjg.v19.i3.331.

  PMID: 23372354 BACKGROUND

• von Rahden BH, Stein HJ, Becker K, Liebermann-Meffert D, Siewert JR. Heterotopic gastric mucosa of the esophagus: literature-review and proposal of a clinicopathologic classification. Am J Gastroenterol. 2004 Mar;99(3):543-51. doi: 10.1111/j.1572-0241.2004.04082.x.

  PMID: 15056100 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Argon Plasma Coagulation

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Electrocoagulation; Cautery; Therapeutics; Hemostatic Techniques; Ablation Techniques; Surgical Procedures, Operative; Hemostasis, Surgical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Patients will be randomized into 1 of 2 treatment arms

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)