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Gastroesophageal Reflux Disease (GERD)Phase 2NCT01025739

Evaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication (TIF) Using EsophyX for the Treatment of GERD

A Phase 2 study testing EsophyX™ system with SerosaFuse fasteners in people with Gastroesophageal Reflux Disease (GERD), run by University of Alberta at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Objectives of the Study: The primary objective of this study is to evaluate the relative merits, safety and effectiveness of the tailored TIF2 procedure in treating GERD patients who have persistent GERD symptoms despite PPI therapy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastroesophageal Reflux Disease (GERD)
What is being tested?
EsophyX™ system with SerosaFuse fasteners
Type of treatment
Medical device
How many people
0 participants
Where
1 siteCanada
Study dates
Jan 2010to Feb 2011
Phase
Phase 2
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-70 years
  • On daily PPIs for > 6 months
  • Persistent GERD symptoms despite PPI therapy
  • Anatomic disruption of the gastroesophageal valve to a Hill Grade II-III
  • Evidence of one of the following while on PPI therapy:
  • Erosive esophagitis (erosions or ulcerations during endoscopy)
Show all 12Show fewer
  • Abnormal ambulatory pH study
  • Biopsy confirmed changes characteristic of reflux esophagitis
  • Acceptable esophageal motility (by either manometry or video esophagogram)
  • Hiatal hernia no larger than 2 cm
  • Patient willing to cooperate with post-operative dietary recommendations and assessment tests
  • Signed informed consent

Who cannot join

  • BMI > 40
  • Hiatal hernia > 2 cm
  • Esophagitis grade D
  • Esophageal ulcer
  • Esophageal stricture
  • Esophageal motility disorder
Show all 16Show fewer
  • Prior splenectomy
  • Pregnancy or plans for pregnancy in the next 12 months (in females)
  • Immunosuppression
  • ASA > 2
  • Portal hypertension and/or varices
  • 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
  • Active gastro-duodenal ulcer disease
  • Gastric outlet obstruction or stenosis
  • Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
  • Coagulation disorders

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • CAMIS, Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

Other trials in Canada

About this study

Official title: Phase II Study of Evaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication (TIF) Using EsophyX for the Treatment of GERD

Objectives of the Study:

The primary objective of this study is to evaluate the relative merits, safety and effectiveness of the tailored TIF2 procedure in treating GERD patients who have persistent GERD symptoms despite PPI therapy.

Read more

The secondary objective of the study is to evaluate the effectiveness of the tailored TIF procedure in restoring the antireflux barrier and eliminating GE reflux.

Type of Study:

Prospective, non-randomized, uncontrolled Study Duration 12 months Number of Patients 20

Inclusion Criteria:

Age 18-70 years, on daily PPIs for > 6 months, persistent GERD symptoms despite PPI therapy, anatomic disruption of the gastroesophageal valve to a Hill Grade II-III, evidence of one of the following while on PPI therapy: (1) erosive esophagitis (erosions or ulcerations during endoscopy); (2) abnormal ambulatory pH study; or (3) biopsy confirmed changes characteristic of reflux esophagitis; acceptable esophageal motility (by either manometry or video esophagogram), hiatal hernia no larger than 2 cm, patient willing to cooperate with post-operative dietary recommendations and assessment tests, signed informed consent

Exclusion Criteria:

BMI > 40, hiatal hernia > 2 cm, esophagitis grade D, esophageal ulcer, fixed esophageal stricture, gastric motility disorders, previous splenectomy, pregnancy (female), immunosuppression, ASA > 2, portal hypertension and/or varices, 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, active gastro-duodenal ulcer disease, gastric outlet obstruction or stenosis, gastroparesis or delayed gastric emptying, coagulation disorders

Interventions:

Treatment: Tailored transoral incisionless fundoplication (TIF2) using EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA)

Evaluation Criteria:

Primary Outcome Measure 24 hour pH impedance study: change in Johnson DeMeester scores; GERD-HRQOL scores Secondary Outcome Measures PPI usage, GERD symptoms at 6 and 12 months vs. baseline off PPI's, total number of reflux episodes, and Symptom Association Probability while off PPI.

Safety: Adverse events will be mapped to standard terms and reported.

Being tested
EsophyX™ system with SerosaFuse fasteners
Keywords
Gastroesophageal Reflux Disease (GERD), EsophyX
Medical subject headings
Gastroesophageal Reflux

What participants receive

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

  • EsophyX™ system with SerosaFuse fastenersDevice

    The EsophyX™ system with SerosaFuse fasteners (EndoGastric Solutions, Redmond, WA, USA) was designed to reconstruct the gastroesophageal junction through anterior partial fundoplication with tailored delivery of multiple fasteners during a single-device insertion.

What is being measured

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

  1. 24 hour pH impedance study: change in Johnson DeMeester scores; GERD-HRQOL scores

    Measured: 1, 3, 6, 12 month

Secondary outcomes (1)

  1. PPI usage, GERD symptoms at 6 and 12 months vs. baseline off PPI's, total number of reflux episodes, and Symptom Association Probability while off PPI. Safety: Adverse events will be mapped to standard terms and reported.

    Measured: 1 day; 1 week; 1, 3, 6, 12 month

Timeline

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

  1. First posted3 Dec 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Why it stopped: No funding source for device purchasing

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01025739
Sponsor's protocol ID
Pro00004475
Status last verified
Apr 2015
First submitted
2 Dec 2009
Last updated
29 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • El-Serag HB. Time trends of gastroesophageal reflux disease: a systematic review. Clin Gastroenterol Hepatol. 2007 Jan;5(1):17-26. doi: 10.1016/j.cgh.2006.09.016. Epub 2006 Dec 4.

    PubMed 17142109

  • Lundell L. Surgery of gastroesophageal reflux disease: a competitive or complementary procedure? Dig Dis. 2004;22(2):161-70. doi: 10.1159/000080315.

    PubMed 15383757

  • Metz DC. Managing gastroesophageal reflux disease for the lifetime of the patient: evaluating the long-term options. Am J Med. 2004 Sep 6;117 Suppl 5A:49S-55S. doi: 10.1016/j.amjmed.2004.07.009.

    PubMed 15478853

  • Moayyedi P, Talley NJ. Gastro-oesophageal reflux disease. Lancet. 2006 Jun 24;367(9528):2086-100. doi: 10.1016/S0140-6736(06)68932-0.

    PubMed 16798392

  • Nandurkar S, Talley NJ. Epidemiology and natural history of reflux disease. Baillieres Best Pract Res Clin Gastroenterol. 2000 Oct;14(5):743-57. doi: 10.1053/bega.2000.0122.

    PubMed 11003807

  • Smout AJ. The patient with GORD and chronically recurrent problems. Best Pract Res Clin Gastroenterol. 2007;21(3):365-78. doi: 10.1016/j.bpg.2007.01.007.

    PubMed 17544105

  • Stylopoulos N, Rattner DW. The history of hiatal hernia surgery: from Bowditch to laparoscopy. Ann Surg. 2005 Jan;241(1):185-93. doi: 10.1097/01.sla.0000149430.83220.7f.

    PubMed 15622007

  • Jones MP, Sloan SS, Rabine JC, Ebert CC, Huang CF, Kahrilas PJ. Hiatal hernia size is the dominant determinant of esophagitis presence and severity in gastroesophageal reflux disease. Am J Gastroenterol. 2001 Jun;96(6):1711-7. doi: 10.1111/j.1572-0241.2001.03926.x.

    PubMed 11419819

  • Mittal RK. Hiatal hernia: myth or reality? Am J Med. 1997 Nov 24;103(5A):33S-39S. doi: 10.1016/s0002-9343(97)00318-5. No abstract available.

    PubMed 9422620

  • Mittal RK. Hiatal hernia and gastroesophageal reflux: another attempt to resolve the controversy. Gastroenterology. 1993 Sep;105(3):941-3. doi: 10.1016/0016-5085(93)90917-2. No abstract available.

    PubMed 8359662

  • Moss SF, Kidd M, Modlin IM. The status of the hiatus: the role of hernia in gastroesophageal reflux disease. J Clin Gastroenterol 2007;41:S144-S153

  • Rydberg L, Ruth M, Lundell L. Mechanism of action of antireflux procedures. Br J Surg. 1999 Mar;86(3):405-10. doi: 10.1046/j.1365-2168.1999.01025.x.

    PubMed 10201789

  • Ahroni JH, Montgomery KF, Watkins BM. Laparoscopic adjustable gastric banding: weight loss, co-morbidities, medication usage and quality of life at one year. Obes Surg. 2005 May;15(5):641-7. doi: 10.1381/0960892053923716.

    PubMed 15946454

  • Cadiere GB, Rajan A, Rqibate M, Germay O, Dapri G, Himpens J, Gawlicka AK. Endoluminal fundoplication (ELF)--evolution of EsophyX, a new surgical device for transoral surgery. Minim Invasive Ther Allied Technol. 2006;15(6):348-55. doi: 10.1080/13645700601040024.

    PubMed 17190659

  • Jobe BA, O'Rourke RW, McMahon BP, Gravesen F, Lorenzo C, Hunter JG, Bronner M, Kraemer SJ. Transoral endoscopic fundoplication in the treatment of gastroesophageal reflux disease: the anatomic and physiologic basis for reconstruction of the esophagogastric junction using a novel device. Ann Surg. 2008 Jul;248(1):69-76. doi: 10.1097/SLA.0b013e31817c9630.

    PubMed 18580209

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EsophyX™ system with SerosaFuse fasteners in people with Gastroesophageal Reflux Disease (GERD), run by University of Alberta at 1 site in Canada.

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 12 inclusion and 16 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: withdrawn, as of the sponsor's last update on 29 Apr 2015. 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 Canada. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

24 hour pH impedance study: change in Johnson DeMeester scores; GERD-HRQOL scores (time frame: 1, 3, 6, 12 month). 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 NCT01025739, which also lists 24 linked publications.

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 29 Apr 2015.

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