Esophagogastric Junction DistensibilityNCT04450628
Esophagogastric Junction Distensibility During Hiatal Hernia Repair
A study testing EndoFLIP in people with Esophagogastric Junction Distensibility and Hiatal Hernia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The investigators aim to ascertain the effects of hiatal hernia repair and fundoplication on the distensibility of the esophagogastric junction (EGJ) as measured by FLIP topography/impedance planimetry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagogastric Junction Distensibility, Hiatal Hernia
- What is being tested?
- EndoFLIP
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 3 Sep 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing hiatal hernia repair (types I-IV included) and fundoplication
- Absence of spastic esophageal disorders (i.e. jackhammer esophagus, achalasia types I-III) assessed by preoperative high-resolution manometry
- Adult patients ≥18 years
- Elective repairs
Who cannot join
- Redo hiatal hernia repairs
- Emergent repairs
- Patients with contraindication to surgery or endoscopy
- Patients with esophageal varices
- Cases with insufficient esophageal length in which fundoplication is unable to be performed or a Collis gastroplasty is required
- Connective tissue diseases such as scleroderma or lupus
- Diameter measurements less than 5 mm as the EF-325N catheter is not suitable
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, 28203
About this study
The investigators aim to ascertain the effects of hiatal hernia repair and fundoplication on the distensibility of the esophagogastric junction (EGJ) as measured by FLIP topography/impedance planimetry. The investigators also aim to assess for any correlation between values of EGJ distensibility and GERD related quality of life (QOL) and dysphagia scores.
Read the detailed description
Patients referred for antireflux surgery and/or hiatal hernia repair will be considered for enrollment. Standard preoperative evaluation will include esophagogastroduodenoscopy (EGD) to assess for intraluminal pathology including esophagitis, columnar lined esophagus suggestive of Barrett's esophagus, intraluminal masses, and to measure hernia size. Patients will also undergo preoperative high resolution esophageal manometry testing with impedance as clinically indicated to evaluate esophageal motility as assessed by standardized Chicago Classification V3. Manometry will occasionally be avoided in patients with paraesophageal hernias without substantial dysphagia or those not amenable to manometry, with appropriate upper gastrointestinal radiology imaging (UGI), who will be having partial fundoplications. UGI is also a routine preoperative evaluation. Furthermore, pH testing for evaluation of acid reflux will be performed in patients without LA grade C or D esophagitis, paraesophageal hernia, or pathologic confirmation of Barrett's esophagus.
Patients appropriate for enrollment will be consented in the office setting. Preoperative baseline evaluations of symptom severity will be assessed via the GERD-HRQL survey and Mayo Dysphagia Questionnaire. Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.
No adjustment will be made to the surgical procedure based on EndoFLIP results, as the operating surgeon will not be informed of the measured values. The EndoFLIP catheters and generator will be provided by Medtronic, at no cost to the patient. Medtronic will also cover the fees associated with the EndoFLIP procedure (CPT 91040 is used).
Postoperative clinical care will proceed as per standard protocol for foregut surgery, with 1 additional office visit. Reports of postoperative symptomatology and quality of life will be performed, via GERD-HRQL and Mayo Dysphagia Questionnaire during follow up clinic appointments at 2 weeks and 6 weeks postoperative, and with additional long-term follow-up of at 6 months. Long-term follow-up will again assess for quality of life symptoms via GERD-HRQL and the Mayo Dysphagia Questionnaire. The 6 month follow-up visit is not typical practice and the patients cost for this visit will be covered by Medtronic. Per standard clinical care, recurrence of symptoms or dysphagia at any point may lead to additional postoperative testing, including UGI, EGD, pH testing, esophageal manometry, CT scan, or EndoFLIP. Postoperative GERD-HRQL and Mayo Dysphagia score results will be compared to intraoperative EndoFLIP measurements in interim and final analysis.
- Being tested
- EndoFLIP
- Keywords
- EndoFLIP, Distensibility of the esophagogastric junction, Gastroesophageal Reflux Disease-Health Related Quality of Life survey, Mayo Dysphagia Questionnaire
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoFLIPDevice
Intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the esophagogastric junction using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.
| Study group | Role | What they receive |
|---|---|---|
| Hiatal Hernia Repair Patients | Experimental | Patients undergoing hiatal hernia repair (types I-IV included) and fundoplication Receives: Device: EndoFLIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Distensibility Index
Distensibility index of esophagogastric junction will be measured with 8cm EndoFLIP balloon at baseline and after hiatal hernia repair.
Measured: Baseline to day 1
Secondary outcomes (2)
Gastroesophageal Reflux Disease Health Related Quality of Life Questionnaire (GERD-HRQL) Score
Postoperative symptoms as measured by GERD-HRQL. Total score range is 0-75. Higher scores are correlated with worse outcomes.
Measured: baseline, postop week 2, postop week 6, postop month 6
Mayo Dysphagia Questionnaire (MDQ-30) Score
Postoperative symptoms as measured by the MDQ-30. Totals core range is 0-100. Higher scores are correlated with worse outcomes.
Measured: baseline, postop week 2, postop week 6, postop month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start28 Sep 2020
- Primary completion3 Sep 2026
- Study completion3 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophagogastric Junction DistensibilityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Paul D Colavita, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450628
- Sponsor's protocol ID
- IRB00081655
- Other IDs
- 01-20-07, Pro00040539
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2020
- Last updated
- 3 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophagogastric Junction Distensibility During Hiatal Hernia Repair
- ClinicalTrials.gov ID
- NCT04450628
- Acronym / sponsor ID
- IRB00081655
- Keywords
- EndoFLIP, Distensibility of the esophagogastric junction, Gastroesophageal Reflux Disease-Health Related Quality of Life survey, Mayo Dysphagia Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 3 Sep 2026 (actual)
- Study completion
- 3 Sep 2026 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Posted 3 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to ascertain the effects of hiatal hernia repair and fundoplication on the distensibility of the esophagogastric junction (EGJ) as measured by FLIP topography/impedance planimetry. The investigators also aim to assess for any correlation between values of EGJ distensibility and GERD related quality of life (QOL) and dysphagia scores.
Detailed description
Patients referred for antireflux surgery and/or hiatal hernia repair will be considered for enrollment. Standard preoperative evaluation will include esophagogastroduodenoscopy (EGD) to assess for intraluminal pathology including esophagitis, columnar lined esophagus suggestive of Barrett's esophagus, intraluminal masses, and to measure hernia size. Patients will also undergo preoperative high resolution esophageal manometry testing with impedance as clinically indicated to evaluate esophageal motility as assessed by standardized Chicago Classification V3. Manometry will occasionally be avoided in patients with paraesophageal hernias without substantial dysphagia or those not amenable to manometry, with appropriate upper gastrointestinal radiology imaging (UGI), who will be having partial fundoplications. UGI is also a routine preoperative evaluation. Furthermore, pH testing for evaluation of acid reflux will be performed in patients without LA grade C or D esophagitis, paraesophageal hernia, or pathologic confirmation of Barrett's esophagus.
Patients appropriate for enrollment will be consented in the office setting. Preoperative baseline evaluations of symptom severity will be assessed via the GERD-HRQL survey and Mayo Dysphagia Questionnaire. Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.
No adjustment will be made to the surgical procedure based on EndoFLIP results, as the operating surgeon will not be informed of the measured values. The EndoFLIP catheters and generator will be provided by Medtronic, at no cost to the patient. Medtronic will also cover the fees associated with the EndoFLIP procedure (CPT 91040 is used).
Postoperative clinical care will proceed as per standard protocol for foregut surgery, with 1 additional office visit. Reports of postoperative symptomatology and quality of life will be performed, via GERD-HRQL and Mayo Dysphagia Questionnaire during follow up clinic appointments at 2 weeks and 6 weeks postoperative, and with additional long-term follow-up of at 6 months. Long-term follow-up will again assess for quality of life symptoms via GERD-HRQL and the Mayo Dysphagia Questionnaire. The 6 month follow-up visit is not typical practice and the patients cost for this visit will be covered by Medtronic. Per standard clinical care, recurrence of symptoms or dysphagia at any point may lead to additional postoperative testing, including UGI, EGD, pH testing, esophageal manometry, CT scan, or EndoFLIP. Postoperative GERD-HRQL and Mayo Dysphagia score results will be compared to intraoperative EndoFLIP measurements in interim and final analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hiatal Hernia Repair Patients | Experimental | Device: EndoFLIPPatients undergoing hiatal hernia repair (types I-IV included) and fundoplication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient undergoing hiatal hernia repair (types I-IV included) and fundoplication
- Absence of spastic esophageal disorders (i.e. jackhammer esophagus, achalasia types I-III) assessed by preoperative high-resolution manometry
- Adult patients ≥18 years
- Elective repairs
Key exclusion criteria (7 listed)
- Redo hiatal hernia repairs
- Emergent repairs
- Patients with contraindication to surgery or endoscopy
- Patients with esophageal varices
- Cases with insufficient esophageal length in which fundoplication is unable to be performed or a Collis gastroplasty is required
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 |
|---|---|---|
| EndoFLIPIntraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the esophagogastric junction using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication. | Device | Hiatal Hernia Repair Patients |
Primary outcome
Change in Distensibility Index
Time frame: Baseline to day 1
Distensibility index of esophagogastric junction will be measured with 8cm EndoFLIP balloon at baseline and after hiatal hernia repair.
2 secondary outcomes
Gastroesophageal Reflux Disease Health Related Quality of Life Questionnaire (GERD-HRQL) Score
Time frame: baseline, postop week 2, postop week 6, postop month 6
Mayo Dysphagia Questionnaire (MDQ-30) Score
Time frame: baseline, postop week 2, postop week 6, postop month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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. This study is not recruiting at the moment.
Paul D Colavita, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoFLIP in people with Esophagogastric Junction Distensibility and Hiatal Hernia, run by Wake Forest University Health Sciences at 1 site 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 3 Nov 2026. 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 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?
Yes. Results are posted in the registry (first posted 3 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Distensibility Index (time frame: Baseline to day 1). 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 3 Nov 2026.