FundoplicationHEURISTICNCT03280121
Hernia Reduction Prior to Scheduled TIF Completion
A study testing EsophyX ZR transoral device in people with Fundoplication, run by EndoGastric Solutions at 3 sites in United States.
Trial summary
Hernia Reduction Prior to Scheduled TIF Completion using EsophyX ZR transoral device Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Fundoplication
- What is being tested?
- EsophyX ZR transoral device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Oct 2018to 26 Oct 2020
- 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 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-72 years
- Dependent upon daily PPIs for > 6 months. Daily use is defined as a double dose, or full dose or half dose taken daily for more than 80% of the total number of days during the proceeding evaluation period
- Troublesome symptoms, specifically heartburn or regurgitation, while on optimized dose of PPI's Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2 days a week and are mild to severe in severity
- Abnormal ambulatory (Bravo) pH study after off PPI therapy for 7 days, i.e. > 5.3% of the time with pH < 4 in a 48-hour monitoring period
- Normal or near normal esophageal motility (by Upper GI/ esophagram or manometry as required)
- Pre-enrollment Hiatal Hernia (axial height and transverse dimension) from > 2 cm up to 4 cm inclusive.
Show all 11Show fewer
- Patient willing to cooperate with post-operative dietary recommendations and assessment tests at the requisite follow-up visits
- Signed informed consent Exclusion Criteria
- 1. BMI > 35 2. Hiatal hernia ≤ 2 and > 4 cm 3. Esophagitis Los Angeles grade C or D 4. Esophageal ulcer 5. Esophageal stricture 6. Long-segment Barretts esophagus (Prague: C > 1, M > 3) 7. Esophageal motility disorder 8. Pregnancy or plans for pregnancy in the next 12 months (in females) 9. Immunosuppression 10. ASA > 2 11. Portal hypertension and/or varices 12. History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis 13. Active gastro-duodenal ulcer disease 14. Gastric outlet obstruction or stenosis 15. Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment 16. Coagulation disorders 17. Atypical symptoms including gas bloat and dysphagia. 18. Any other presenting condition that in the opinion of the investigator would not make participation in this study in the patient's best interest.
- Post Enrollment Exclusion -
- 1. Inability to repair Hiatal hernia with at least 2cm of intra-abdominal esophagus length.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Elkhart General Hospital
Elkhart, Indiana, 46514
Aspirus Iron River Hospital
Iron River, Michigan, 49935
Northern Nevada Medical Center
Sparks, Nevada, 89434
About this study
Official title: Hernia Reduction Prior to Scheduled TIF Completion- The HEURISTIC Study
Hernia Reduction Prior to Scheduled TIF Completion using EsophyX ZR transoral device
Read the detailed description
Evaluation of the relative merits, safety and effectiveness of the EsophyX ZR transoral device in performing the standardized TIF 2.0 procedure preceded by laparoscopic Hiatal Hernia repair in PPI-prescribed patients with persistent "troublesome symptoms" per the Montreal consensus definition
- Conditions
- Fundoplication
- Being tested
- EsophyX ZR transoral device
- Keywords
- transoral incisionless
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophyX ZR transoral deviceDevice
TIF
| Study group | Role | What they receive |
|---|---|---|
| TIF using EsophyX ZR transoral device | Experimental | Transoral incisionless fundoplication which is a minimally invasive treatment for gastroesophageal reflux disease (GERD) using EsophyX ZR transoral device Receives: Device: EsophyX ZR transoral device |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH Study
Number of Participants with Normalization of Esophageal Acid Exposure. Normalization in esophageal acid exposure is defined by ≤ 5.3% of total time pH < 4 in
Measured: 48 hour monitoring period
Secondary outcomes (2)
Number of Participants With a Change in Troublesome Symptoms From Baseline
Per Montreal Consensus definition, troublesome symptoms are mild symptoms occurring two (2) or more days per week, or moderate/severe symptoms occurring more than 1 day per week
Measured: 6 months
Number of Participants With a Change in PPI Consumption From Baseline to 6 Months
from daily use to occasional use or none at all.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start5 Oct 2018
- Primary completion30 Apr 2020
- Study completion26 Oct 2020
Why it stopped: Slow enrollment and Covid-19
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 FundoplicationStudies of the same condition, open and under way.
- 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
- Model description
- Prospective, investigator initiated, multicenter, non-randomized single arm, open label.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoGastric Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Murray, MD,FACS, Principal investigator, Northern Nevada Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280121
- Sponsor's protocol ID
- D031517
- Acronym
- HEURISTIC
- Status last verified
- Oct 2020
- First submitted
- 9 Sep 2017
- Last updated
- 10 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hernia Reduction Prior to Scheduled TIF Completion- The HEURISTIC Study
- ClinicalTrials.gov ID
- NCT03280121
- Acronym / sponsor ID
- HEURISTIC / D031517
- Conditions
- Fundoplication
- Keywords
- transoral incisionless
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment and Covid-19
- Enrolment
- 14 participants (actual)
- Lead sponsor
- EndoGastric SolutionsIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Posted 7 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hernia Reduction Prior to Scheduled TIF Completion using EsophyX ZR transoral device
Detailed description
Evaluation of the relative merits, safety and effectiveness of the EsophyX ZR transoral device in performing the standardized TIF 2.0 procedure preceded by laparoscopic Hiatal Hernia repair in PPI-prescribed patients with persistent "troublesome symptoms" per the Montreal consensus definition
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, investigator initiated, multicenter, non-randomized single arm, open label.
| Arm | Type | Receives |
|---|---|---|
| TIF using EsophyX ZR transoral device | Experimental | Device: EsophyX ZR transoral deviceTransoral incisionless fundoplication which is a minimally invasive treatment for gastroesophageal reflux disease (GERD) using EsophyX ZR transoral device |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-72 years
- Dependent upon daily PPIs for > 6 months. Daily use is defined as a double dose, or full dose or half dose taken daily for more than 80% of the total number of days during the proceeding evaluation period
- Troublesome symptoms, specifically heartburn or regurgitation, while on optimized dose of PPI's Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2 days a week and are mild to severe in severity
- Abnormal ambulatory (Bravo) pH study after off PPI therapy for 7 days, i.e. > 5.3% of the time with pH < 4 in a 48-hour monitoring period
- Normal or near normal esophageal motility (by Upper GI/ esophagram or manometry as required)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EsophyX ZR transoral deviceTIF | Device | TIF using EsophyX ZR transoral device |
Primary outcome
pH Study
Time frame: 48 hour monitoring period
Number of Participants with Normalization of Esophageal Acid Exposure. Normalization in esophageal acid exposure is defined by ≤ 5.3% of total time pH < 4 in
2 secondary outcomes
Number of Participants With a Change in Troublesome Symptoms From Baseline
Time frame: 6 months
Number of Participants With a Change in PPI Consumption From Baseline to 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Fundoplication
Enrolling by invitationObservational study
Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus
Barrett Esophagus, Transoral Incisionless Fundoplication
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Transoral Incisional Fundoplication (TIF) for Patients Suffering From Gastroesophageal Reflux Disease in an Asian Population
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Not yet recruiting
Clinical Trial on Safety and Efficacy of Thoracoabdominal Endoscopic Surgical System for Pediatric Surgery
Indications for Laparoscopic Thoracic and Abdominal Surgery in Children, Congenital or Acquired Surgical Conditions Requiring Minimally Invasive Surgery in Children
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.
Michael Murray, MD,FACS principal investigator
Northern Nevada Medical Group
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EsophyX ZR transoral device in people with Fundoplication, run by EndoGastric Solutions at 3 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 11 inclusion and 0 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: stopped early, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 7 Jan 2021). 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?
pH Study (time frame: 48 hour monitoring period). 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 10 Feb 2021; AzTrials last refreshed its copy on 28 Oct 2026.