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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects have GERD with hiatal hernia < 5 cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery) and Hill grade III or IV
Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% (worst day) or LA grade C or D esophagitis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
CTIF Trial Summary
This trial will compare the effectiveness and safety of two different treatments for GERD in patients with hiatal hernia who are also having hernia repair surgery.
Who is the study for?
This trial is for adults aged 22-80 with GERD and a hiatal hernia smaller than 5 cm, who have not had previous anti-reflux surgery. Participants must show signs of acid reflux, be able to consent, and commit to the study long-term. Those with severe gastroparesis, large hernias over 5 cm, significant esophageal disorders, or women who are pregnant cannot join.Check my eligibility
What is being tested?
The study compares two treatments for GERD in patients needing hiatal hernia repair: Laparoscopic Hiatal Hernia Repair combined with Transoral Incisionless Fundoplication (TIF) versus standard Laparoscopic Nissen Fundoplication (LNF). Patients will be randomly assigned to either treatment at multiple centers.See study design
What are the potential side effects?
Potential side effects may include discomfort from the procedure, digestive issues such as bloating or gas (known as 'gas bloat syndrome'), difficulty swallowing if too tight a wrap is made around the esophagus during LNF, and anesthesia-related risks.
CTIF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe GERD and a small hiatal hernia.
Select...
My tests show severe acid reflux or serious damage to my esophagus.
Select...
I have severe GERD and a small hiatal hernia.
Select...
I am between 22 and 80 years old.
CTIF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean difference in HRQL score ≤ 15%
Secondary outcome measures
Adverse events rate
Cessation of Proton Pump Inhibitor (PPI) use
Change in AET
+6 moreCTIF Trial Design
2Treatment groups
Active Control
Group I: Combo Transoral Incisionless Fundoplication (CTIF)Active Control1 Intervention
Treatment
Group II: Laparoscopic Nissen Fundoplication (LNF)Active Control1 Intervention
Control
Find a Location
Who is running the clinical trial?
EndoGastric SolutionsIndustry Sponsor
11 Previous Clinical Trials
2,899 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
904 Previous Clinical Trials
320,818 Total Patients Enrolled
Fox Valley Surgical AssociatesUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery to prevent acid reflux.You need to have a surgery that involves using a mesh implant at the same time as the study.My BMI was over 35 at the time of my surgery.You are willing to participate in the study for a long period of time.I have severe GERD and a small hiatal hernia.My tests show severe acid reflux or serious damage to my esophagus.I have not had stomach surgery that affects its function or the ability to perform certain medical procedures.I have severe GERD and a small hiatal hernia.I have severe stomach emptying issues.I am between 22 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Combo Transoral Incisionless Fundoplication (CTIF)
- Group 2: Laparoscopic Nissen Fundoplication (LNF)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Acid Reflux Patient Testimony for trial: Trial Name: NCT04795934 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor open to individuals aged 25 and above?
"This clinical trial is recruiting individuals aged between 22 and 80 years."
Answered by AI
What is the aggregate number of individuals involved in this experiment?
"EndoGastic Solutions, the sponsor of this medical study, is recruiting 142 patients who meet their inclusion criteria. The trial will take place at multiple sites such as University of California Irvine in Austin, Texas and The University of Texas at Austin in Appleton Wisconsin."
Answered by AI
What criteria must be met in order to qualify for participation in this medical experiment?
"Applicants must be between the ages of 22 and 80, as well as possess a hiatus hernia to qualify for this trial. In total, 142 participants are desired by researchers conducting it."
Answered by AI
Is the research study still open to new participants?
"Correct, prospective participants can apply as this trial has been accepting enrollees since January 26th 2021. The study's page on clinicaltrials.gov was recently updated to reflect changes made in June 17th 2022."
Answered by AI
How widely has this research been conducted across different sites?
"The trial is currently enrolling participants at 8 separate sites, including Austin, Appleton and Los Angeles. To make the process as effortless as possible for enrolled patients, it's important to select a location that minimizes travel requirements."
Answered by AI
Who else is applying?
What state do they live in?
South Dakota
Tennessee
California
What site did they apply to?
University of Southern California
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
i have and deal with acid reflux daily, had hiatal hernia repair in 2014. 11/20.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
when do we start?
PatientReceived no prior treatments
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