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GERDCTIFNCT04795934

Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair

A study testing LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION in people with GERD and Hiatal Hernia, run by Mayo Clinic at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This single-blind randomized control study will follow 142 subjects across 7 sites randomized on a 1:1 ratio to compare treatment efficacy and safety between TIF and LNF in GERD patients with hiatal hernia undergoing hernia repair. Read more about this study

Who is it for?
Ages 22 to 80 years
Conditions the study is for
GERD, Hiatal Hernia
What is being tested?
LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
7 sitesUnited States
Study dates
26 Jan 2021to Jan 2030
Phase
Interventional
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 22 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 22-80 years of age
  • 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
  • Pathologic reflux while off PPI based on Lyon criteria by either of the following:
  • 3.1. Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% (worst day) or LA grade C or D esophagitis.
  • 3.2. Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B.
  • Commitment to long-term study
  • Ability to give consent individually or by a legally authorized representative

Who cannot join

  • 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)
  • Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
  • Pregnancy (in females) at time of procedure
  • Previous anti-reflux procedure
  • Subjects requiring mesh treatment at time of procedure
  • At the discretion of the site PI for subject safety
Show all 9Show fewer
  • BMI > 35 at time of surgery.
  • Prior gastric surgery that may affect ability to perform either procedure or affect normal gastric function (e.g. gastrectomy, gastric bypass, sleeve gastrectomy, pyloroplasty.
  • Severe gastroparesis

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Fox Valley Surgical

    Appleton, Wisconsin, 54911

  • The University of Texas at Austin

    Austin, Texas, 78712

  • Institute of Esophageal and Reflux Surgery

    Englewood, Colorado, 880113

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • University of California Irvine

    Irvine, California, 92697

  • University of Southern California

    Los Angeles, California, 90033

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair Combined With Transoral Incisionless Fundoplication Versus Laparoscopic Nissen Fundoplication for Treatment of Gastroesophageal Reflux Disease in Patients Requiring Hiatal Hernia Repair

This single-blind randomized control study will follow 142 subjects across 7 sites randomized on a 1:1 ratio to compare treatment efficacy and safety between TIF and LNF in GERD patients with hiatal hernia undergoing hernia repair.

Conditions
GERD, Hiatal Hernia
Being tested
LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION
Medical subject headings
Gastroesophageal Reflux, Hernia, Hiatal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATIONProcedure or surgery

    Also called LAPAROSCOPIC NISSEN FUNDOPLICATION

    LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION

Study groups in NCT04795934
Study groupRoleWhat they receive
Laparoscopic Nissen Fundoplication (LNF)Active comparatorControl
Receives: Procedure: LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION
Combo Transoral Incisionless Fundoplication (CTIF)Active comparatorTreatment
Receives: Procedure: LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean difference in HRQL score ≤ 15%

    Hypothesis: TIF is non-inferior to LNF as measured by quality of life at 6 months post-procedure using the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) score.

    GERD-HRQL Scoring Total Score: Calculated by summing the individual scores to questions 1-15.

    • Greatest possible score (worst symptoms) = 75
    • Lowest possible score (no symptoms) = 0

    Heartburn Score: Calculated by summing the individual scores to questions 1-6 .

    • Worst heartburn symptoms = 30
    • No heartburn symptoms = 0
    • Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination.

    Regurgitation Score: Calculated by summing the individual scores to questions 10-15.

    • Worst regurgitation symptoms = 30
    • No regurgitation symptoms = 0
    • Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.

    Measured: 6 months

Secondary outcomes (9)

  1. Change in AET

    Upper Endoscopy with 72 Hrs BravoPH Case Report Form

    Measured: [Time Frame: 6 months]

  2. Incidence of bloating

    Dysphagia, Bloating, \& Reflux Symptoms Questionnaire (DBR) Case Report Form

    Measured: [Time Frame: 6 months]

  3. Incidence of dysphagia

    Dysphagia, Bloating, \& Reflux Symptoms Questionnaire (DBR) Case Report Form

    Measured: [Time Frame: 6 months]

  4. Change in distensibility index of GE junction

    Endoflip (optional) Case Report Form

    Measured: [Time Frame: 6 months]

  5. Cessation of Proton Pump Inhibitor (PPI) use

    PPI Use Questionnaire Case Report Form

    Measured: [Time Frame: 6 months]

  6. Healing of esophagitis

    Upper Endoscopy with 72 Hrs BravoPH Case Report Form assessing LA Grade system: A, B, C, or D (if present)

    Grade A One (or more) mucosal break no longer than 5 mm that does not extend between the tops of two mucosal folds Grade B One (or more) mucosal break more than 5 mm long that does not extend between the tops of two mucosal folds Grade C One (or more) mucosal break that is continuous between the tops of two or more mucosal folds but which involve less than 75% of the circumference Grade D One (or more) mucosal break which involves at least 75% of the esophageal circumference

    Measured: [Time Frame: 6 months]

  7. Recurrence of hiatal hernia

    Upper Endoscopy with 72 Hrs BravoPH Case Report Form

    Measured: [Time Frame: 6 months]

  8. Hill grade of GE junction

    Upper Endoscopy with 72 Hrs BravoPH Case Report Form

    Measured: [Time Frame: 6 months]

  9. Adverse events rate

    Adverse Event Case Report Form

    Measured: [Time Frame: 6 months]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2021
  2. Study start26 Jan 2021
  3. Primary completion31 Jul 2025
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04795934
Sponsor's protocol ID
19-005226
Acronym
CTIF
Status last verified
Sep 2026
First submitted
10 Feb 2021
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Health information may be collected from: Past, present and future medical records. Research procedures, including research office visits, tests, interviews and questionnaires. Health information will be used and/or given to others to: Do the research. Report the results. See if the research was conducted following the approved study plan, and applicable rules and regulations. Health information may be used and shared with: Mayo Clinic research staff involved in this study or clinical care. Researchers involved in this study at other institutions. The sponsor of this study and the people or groups hired by the sponsor to help perform this research. The Mayo Clinic Institutional Review Board that oversees the research. Federal and State agencies (such as the Food and Drug Administration, the Department of Health and Human Services, the National Institutes of Health and other United States agencies) or government agencies in other countries that oversee or review research.

Publications

  • Kolb JM, Canto MI, Parker B, Murray M, Brewer Gutierrez OI, Sharaiha RZ, Abu-Dayyeh BK, Janu P, Chang KJ, Nguyen NT. Short-Term Outcomes of Laparoscopic Hiatal Hernia Repair with Consecutive Transoral Incisionless Fundoplication: A Prospective Multicenter Cohort Study. J Am Coll Surg. 2026 Nov 1;243(5):1220-1229. doi: 10.1097/XCS.0000000000002059. Epub 2026 Jun 3.

    PubMed 42233490

Questions about this trial

What is this clinical trial studying?

A study testing LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION in people with GERD and Hiatal Hernia, run by Mayo Clinic at 7 sites in United States.

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 7 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean difference in HRQL score ≤ 15% (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04795934, which also lists 1 linked publication.

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 3 Sep 2026.

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