Stretta Treatment in GERD After SG

NCT05094895 | Unknown

• 1 other identifier: S64212
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect and explore the mechanism of action behind the potential effect of Stretta® on GERD after SG.

Conditions

Stretta Device

Outcome Measures

Primary Outcomes (4)

• Symptom severity

  Primary efficacy endpoint will be the change in symptom severity assessed by validated reflux questionnaires (ReQuest questionnaire and diaries) at week -1

  ReQuest questionnaire score will be assessed at week -1 after treatment

• Symptom severity

  Primary efficacy endpoint will be the change in symptom severity assessed by validated reflux questionnaires (ReQuest questionnaire and diaries) at week 12

  ReQuest questionnaire score will be assessed at week 12 after treatment

• Symptom severity

  Primary efficacy endpoint will be the change in symptom severity assessed by validated reflux questionnaires (ReQuest questionnaire and diaries) at week 24

  ReQuest questionnaire score will be assessed at week 24 after treatment

• Symptom severity

  Primary efficacy endpoint will be the change in symptom severity assessed by validated reflux questionnaires (ReQuest questionnaire and diaries) 1 year after treatment

  ReQuest questionnaire score will be assessed at 1 year after treatment

Secondary Outcomes (6)

• Objective reflux parameters

  Will be assessed week -1, week 12 and week 24

• High Resolution impedance manometry

  Will be assessed week -1 and week 24

• EGJ distensibility (Endoflip)

  Will be assessed week -1 and week 24

• Esophageal sensitivity

  Will be assessed week -1 and week 24

• Esophageal permeability

  Will be assessed week -1 and week 24

Study Arms (2)

Stretta Treatment

ACTIVE COMPARATOR

Patients will receive the Stretta treatment

Procedure: Stretta

Sham treatment

SHAM COMPARATOR

Patients will receive the sham treatment

Procedure: Sham

Interventions

Stretta PROCEDURE

Radiofrequency energy delivered to the gastro-esophageal junction

Stretta Treatment

Sham PROCEDURE

Patients that have the sham condition will have a procedure using a 24Fr Savary bougie dilator over the guidewire, with the same sedation.

Sham treatment

Eligibility Criteria

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

You may qualify if:

• to 65 years old;
• History of typical GERD symptoms (heartburn or regurgitation) during PPI treatment, at least 3 times per week for 12 weeks ('refractory GERD') or unwillingness to take/continue PPIs. The symptoms can be de novo (onset after sleeve gastrectomy) or pre-existing (as documented by medication use, findings during endoscopy or medical history);
• In case of refractory GERD symptoms during PPI treatment the following criteria need to be fulfilled: Pathological catheter-based 24h pH-MII monitoring off-PPI (\>6% of total time pH\<4 and/or number of reflux episodes \>80 (irrespective of acidity) or positive symptom association probability (SAP) for typical reflux symptoms) based on the Lyon consensus (23);
• More than 12 months after sleeve gastrectomy;
• Willing to take contraceptive measurements.

You may not qualify if:

• Hiatal hernia of \>2cm as determined during HRiM (based on Chicago Classification v3.0. (24)) and/or endoscopy or hiatal hernia repair;
• Esophagitis LA classification grade C or D during gastroscopy off-PPI;
• Circumferential Barrett's esophagus \>1cm (columnar lined esophageal mucosa with intestinal metaplasia) or history of ablation of Barrett's esophagus;
• Esophageal or fundus varices during gastroscopy;
• Esophageal strictures during gastroscopy;
• Abnormalities in sleeve (e.g. sleeve migration) observed during gastroscopy and/or barium test;
• Known cirrhosis or portal hypertension from other causes;
• History of surgery to the upper gastrointestinal tract other than sleeve gastrectomy, including redo after previous bariatric surgery;
• Autoimmune or a connective tissue disorder (scleroderma, dermatomyositis, Calcinosis-Raynaud's-Esophagus Sclerodactily Syndrome (CREST), Sjogren's Syndrome, etc.);
• Achalasia, EGJ-outflow obstruction, jackhammer esophagus or absent contractility as defined by the 3rd revision of the Chicago classification for primary esophageal motility disorders24 assessed during HRiM with meal (see study protocol (25));
• Significant cardiopulmonary or other comorbidity precluding safe sedation;
• Pacemaker or implanted cardiac defibrillator;
• Coagulopathy or use of anticoagulants;
• Pregnancy or breastfeeding
• Unable or unwilling to consent for an invasive procedure.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Timshel BV: collaborator

Study Sites (1)

Annelies Geeraerts

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Interventions

salicylhydroxamic acid

Central Study Contacts

Annelies Geeraerts

CONTACT

+321643385; annelies.geeraerts@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: In the first period are the patients and investigators blinded. Afterwards there is an open label period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Patients will receive the Stretta treatment or the Sham treatment. Patients assigned to the Sham treatment condition, will have an open label period and are able to receive the Stretta treatment as wel.

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: October 26, 2021
• Study Start: January 29, 2021
• Primary Completion: January 29, 2024
• Study Completion: January 29, 2024
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

BE (1)