Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)

NCT05066594 | Recruiting DMC FDA Device

• 1 other identifier: TIF REGISTRY 2021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This observational registry aims to: 1) record the TIF interventions in patients with esophageal or extra-esophageal symptoms; 2) to monitor the therapy response through the clinical experience in terms of effect on the use and dosage of proton pump inhibitors (PPIs) and on the GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaires scores; 3) to characterize the treated patients population and the predictive factors of TIF success, identifying the subpopulation who may effectively benefit from TIF.

Conditions

Gastro Esophageal Reflux

Keywords

Fundoplication; Endoscopy, Digestive System; Gastro Esophageal Reflux

Outcome Measures

Primary Outcomes (1)

• Medical use and dosage

  Need to use proton pump inhibitors (PPI), and at what dosage, to control the gastro-esophageal reflux symptoms after intervention

  Yearly, up to 5 years from the date of the intervention

Secondary Outcomes (9)

• Health Related Quality of Life questionnaire score

  Yearly, up to 5 years from the date of the intervention

• Reflux Symptom Index questionnaire score

  Yearly, up to 5 years from the date of the intervention

• Esophagitis

  6 months and 12 months after the date of the intervention

• Hill's grade of the gastro-esophageal flap valve

  6 months and 12 months after the date of the intervention

• Jobe's length of the gastro-esophageal valve

  6 months and 12 months after the date of the intervention

Study Arms (1)

Transoral incisionless fundoplication with EsophyX device (EndoGastric Solutions)

Patients treated by transoral incisionless fundoplication (TIF) using the EsophyX device (EndoGastric Solutions) for gastro-esophageal reflux disease will be enrolled in the registry and clinically followed-up for 5 years from the date of TIF procedure.

Device: Transoral incisionless fundoplication

Interventions

Transoral incisionless fundoplication DEVICE

The intervention of transoral incisionless fundoplication using the EsophyX (EndoGastric Solutions) system allows, through the endoscopic route, the creation of a cardial neovalve of approximately 270 ° by placing 20-28 polyethylene sutures on the cardial circumference, resulting in an anti-reflux plastic functionally similar to that obtained with the surgical fundoplication.

Transoral incisionless fundoplication with EsophyX device (EndoGastric Solutions)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion criteria for TIF: \>12 months esophageal or extraesophageal symptoms from gastroesophageal reflux, despite \>6 months therapy with PPI; cardial valve Hill's degree \>III; pathological gastroesophageal reflux; hiatal hernia ≤2 cm. Exclusion criteria for TIF: hiatal hernia \>2 cm; paraesophageal hernia; severe esophageal motility disorder or Los Angeles grade C and D esophagitis; esophageal stenosis, diverticula, infections; pregnancy, breastfeeding; bleeding disorders; malignant neoplasm; immunosuppressant therapy; portal hypertension; esophageal varices; eosinophilic esophagitis; autoimmune esophagitis; BMI ≥35; limited mobility of the neck; patients for whom the use of the EsophyX device is contraindicated.

You may qualify if:

• Clinical indication to undergo transoral incisionless fundoplication (TIF) with the EsophyX device for treatment of chronic gastro-esophageal reflux disease;
• Availability for prolonged follow-up (5 years) after TIF at San Raffaele Hospital;
• Signed informed consent for participation in the observational registry.

You may not qualify if:

• Absence of clinical indication to undergo transoral incisionless fundoplication (TIF) with the EsophyX device for treatment of chronic gastro-esophageal reflux disease;
• Unavailability for prolonged follow-up (5 years) after TIF at San Raffaele Hospital;
• No signed informed consent for participation in the observational registry.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Study Officials

• Pier Alberto Testoni, Prof.

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pier Alberto Testoni, MD, Prof.

CONTACT

+39 02/26432756; testoni.pieralberto@hsr.it

Sabrina Gloria Giulia Testoni, MD, PhD

CONTACT

+39 02/26436303; testoni.sabrinagloriagiulia@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastroenterology and Digestive Endoscopy

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: October 4, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2029
• Last Updated: October 4, 2021

Record last verified: 2021-09

Locations

IT (1)