Gastro Esophageal RefluxTIF/2021NCT05066594
Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)
An observational study of Gastro Esophageal Reflux, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastro Esophageal Reflux
- What is being tested?
- Transoral incisionless fundoplication
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2021to May 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Milan, 20132
Pier Alberto Testoni, MD, Prof., +39 02/26432756, testoni.pieralberto@hsr.it
Sabrina Gloria Giulia Testoni, MD, PhD, +39 02/26436303, testoni.sabrinagloriagiulia@hsr.it
About this study
Official title: Observational Registry of Transoral Incisionless Fundoplication (Creation of a New Gastroesophageal Valve) in Patients With Gastroesophageal Reflux Disease
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.
Read the detailed description
After being evaluated according to the clinical indication for the treatment of symptomatic gastro-esophageal reflux disease (GERD with esophageal or extraesophageal symptoms) by transoral incisionless fundoplication (TIF) and, thus, being treated by TIF using the EsophyX device, all patients giving specific informed consent will enter a 3-year enrollment registry with a 5-year follow-up for each patient through post-TIF routine practice visits and examinations.
- Conditions
- Gastro Esophageal Reflux
- Being tested
- Transoral incisionless fundoplication
- Keywords
- Fundoplication, Endoscopy, Digestive System, Gastro Esophageal Reflux
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral incisionless fundoplicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transoral incisionless fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical use and dosage
Need to use proton pump inhibitors (PPI), and at what dosage, to control the gastro-esophageal reflux symptoms after intervention
Measured: Yearly, up to 5 years from the date of the intervention
Secondary outcomes (9)
Health Related Quality of Life questionnaire score
Modification of the scores from the gastro-esophageal reflux disease-health related quality of life (GERD-HRQL) questionnaire (off proton pump inhibitors), according to a Likert scale from 0 (absence of symptoms) to 5 (symptoms do not allow for normal daily activity), after intervention compared with baseline
Measured: Yearly, up to 5 years from the date of the intervention
Reflux Symptom Index questionnaire score
Modification of the scores from the reflux symptom index (GERD-RSI) questionnaire (off proton pump inhibitors), according to a Likert scale from 0 (no problem) to 5 (severe problem) after the intervention compared with baseline
Measured: Yearly, up to 5 years from the date of the intervention
Esophagitis
Presence and degree of esophagitis according to the Los Angeles classification (grade A, grade B, grade C, grade D) after the intervention
Measured: 6 months and 12 months after the date of the intervention
Hill's grade of the gastro-esophageal flap valve
Degree of continence of the neo gastro-esophageal flap valve according to the Hill classification (grade I, grade II, grade III, grade IV) after the intervention
Measured: 6 months and 12 months after the date of the intervention
Jobe's length of the gastro-esophageal valve
Length of the fold of the neo gastro-esophageal valve according to the criteria of Jobe et al. after the intervention
Measured: 6 months and 12 months after the date of the intervention
Barrett's esophagus
Presence and degree of Barrett's esophagus according to the Prague classification (C, M) after the intervention
Measured: 6 months and 12 months after the date of the intervention
High-resolution esophageal manometry findings
Esophageal manometry measurements after the intervention
Measured: 12 months after the date of the intervention
24-hour esophageal pH-metry findings
24-hour esophageal pH-metry measurements off proton pump inhibitors after the intervention
Measured: 12 months and 24 months after the date of the intervention
24-hour esophageal impedancemetry findings
24-hour esophageal pH-impedance measurements off proton pump inhibitors after the intervention
Measured: 12 months and 24 months after the date of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 May 2021
- Primary completionMay 2026 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pier Alberto Testoni, IRCCS San Raffaele
- Investigators
- Pier Alberto Testoni, Prof., Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066594
- Sponsor's protocol ID
- TIF REGISTRY 2021
- Acronym
- TIF/2021
- Status last verified
- Sep 2021
- First submitted
- 29 Apr 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Registry of Transoral Incisionless Fundoplication (Creation of a New Gastroesophageal Valve) in Patients With Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT05066594
- Acronym / sponsor ID
- TIF/2021 / TIF REGISTRY 2021
- Conditions
- Gastro Esophageal Reflux
- Keywords
- Fundoplication, Endoscopy, Digestive System, Gastro Esophageal Reflux
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After being evaluated according to the clinical indication for the treatment of symptomatic gastro-esophageal reflux disease (GERD with esophageal or extraesophageal symptoms) by transoral incisionless fundoplication (TIF) and, thus, being treated by TIF using the EsophyX device, all patients giving specific informed consent will enter a 3-year enrollment registry with a 5-year follow-up for each patient through post-TIF routine practice visits and examinations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transoral incisionless fundoplication with EsophyX device (EndoGastric Solutions) | – | Device: Transoral incisionless fundoplicationPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transoral incisionless fundoplicationThe 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. | Device | Transoral incisionless fundoplication with EsophyX device (EndoGastric Solutions) |
Primary outcome
Medical use and dosage
Time frame: Yearly, up to 5 years from the date of the intervention
Need to use proton pump inhibitors (PPI), and at what dosage, to control the gastro-esophageal reflux symptoms after intervention
9 secondary outcomes
Health Related Quality of Life questionnaire score
Time frame: Yearly, up to 5 years from the date of the intervention
Reflux Symptom Index questionnaire score
Time frame: Yearly, up to 5 years from the date of the intervention
Esophagitis
Time frame: 6 months and 12 months after the date of the intervention
Hill's grade of the gastro-esophageal flap valve
Time frame: 6 months and 12 months after the date of the intervention
Jobe's length of the gastro-esophageal valve
Time frame: 6 months and 12 months after the date of the intervention
Barrett's esophagus
Time frame: 6 months and 12 months after the date of the intervention
High-resolution esophageal manometry findings
Time frame: 12 months after the date of the intervention
24-hour esophageal pH-metry findings
Time frame: 12 months and 24 months after the date of the intervention
24-hour esophageal impedancemetry findings
Time frame: 12 months and 24 months after the date of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pier Alberto Testoni, Prof. principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro Esophageal Reflux, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pier Alberto Testoni, MD, Prof. (+39 02/26432756, testoni.pieralberto@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical use and dosage (time frame: Yearly, up to 5 years from the date of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.