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

Gastroesophageal Reflux Disease (GERD) Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01025739
• Other study ID #: Pro00004475
• Status: Withdrawn
• Phase: Phase 2
• First received: December 2, 2009
• Last updated: April 27, 2015
• Start date: January 2010
• Est. completion date: February 2011

Study information

• Verified date: April 2015
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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:

• Erosive esophagitis (erosions or ulcerations during endoscopy)

• 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

Exclusion Criteria:

• BMI > 40

• Hiatal hernia > 2 cm

• Esophagitis grade D

• Esophageal ulcer

• Esophageal stricture

• Esophageal motility disorder

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

Intervention

Device:
• EsophyX™ system with SerosaFuse fasteners
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.

Locations

Country	Name	City	State
Canada	CAMIS, Royal Alexandra Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (24)

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. — View Citation

Bouvy ND, Witteman BPL, de Vries E, van Dam JW, Greve JW, Gawlicka AK, Masclee A, Hameeteman W, Koek GH. EsophyX transoral incisionless fundoplication for the treatment of GERD in clinical practice. Surg Endosc 2008

Bouvy ND, Witteman BPL, de Vries E, van Dam R, Greve JW, Gawlicka AK, Masclee A, Hameeteman W, Koek GH. EsophyX transoral incisionless fundoplication for the treatment of GERD in clinical practice. Gastrointest Endosc 2008

Bouvy ND, Witteman BPL, Jobe BA, Lorenzo C, Kraemer SJM, Gawlicka AK, McMahon B, Gravesen FH, Masclee A, Hameeteman W, Koek GH, Perry K. Tailored reconstruction of the esophagogastric junction using transoral incisionless fundoplication: a feasibility study. Surg Endosc 2008

Cadière GB, Buset M, Muls V, Rajan A, Rösch T, Eckardt AJ, Weerts J, Bastens B, Costamagna G, Marchese M, Louis H, Mana F, Sermon F, Gawlicka AK, Daniel MA, Devière J. Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World J Surg. 2008 Aug;32(8):1676-88. doi: 10.1007/s00268-008-9594-9. — View Citation

Cadière GB, Rajan A, Germay O, Himpens J. Endoluminal fundoplication by a transoral device for the treatment of GERD: A feasibility study. Surg Endosc. 2008 Feb;22(2):333-42. Epub 2007 Dec 11. — View Citation

Cadière 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. — View Citation

El-Serag HB. Time trends of gastroesophageal reflux disease: a systematic review. Clin Gastroenterol Hepatol. 2007 Jan;5(1):17-26. Epub 2006 Dec 4. Review. — View Citation

Hill LD, Kozarek RA, Kraemer SJ, Aye RW, Mercer CD, Low DE, Pope CE 2nd. The gastroesophageal flap valve: in vitro and in vivo observations. Gastrointest Endosc. 1996 Nov;44(5):541-7. — View Citation

Huber-Lang M, Henne-Bruns D, Schmitz B, Wuerl P. Esophageal perforation: principles of diagnosis and surgical management. Surg Today. 2006;36(4):332-40. — View Citation

Jobe BA, Kahrilas PJ, Vernon AH, Sandone C, Gopal DV, Swanstrom LL, Aye RW, Hill LD, Hunter JG. Endoscopic appraisal of the gastroesophageal valve after antireflux surgery. Am J Gastroenterol. 2004 Feb;99(2):233-43. — View Citation

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. — View Citation

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. — View Citation

Lundell L. Surgery of gastroesophageal reflux disease: a competitive or complementary procedure? Dig Dis. 2004;22(2):161-70. Review. — View Citation

Lundell LR, Dent J, Bennett JR, Blum AL, Armstrong D, Galmiche JP, Johnson F, Hongo M, Richter JE, Spechler SJ, Tytgat GN, Wallin L. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999 Aug;45(2):172-80. — View Citation

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. Review. — View Citation

Mittal RK. Hiatal hernia and gastroesophageal reflux: another attempt to resolve the controversy. Gastroenterology. 1993 Sep;105(3):941-3. — View Citation

Mittal RK. Hiatal hernia: myth or reality? Am J Med. 1997 Nov 24;103(5A):33S-39S. Review. — View Citation

Moayyedi P, Talley NJ. Gastro-oesophageal reflux disease. Lancet. 2006 Jun 24;367(9528):2086-100. Review. — View Citation

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

Nandurkar S, Talley NJ. Epidemiology and natural history of reflux disease. Baillieres Best Pract Res Clin Gastroenterol. 2000 Oct;14(5):743-57. Review. — View Citation

Rydberg L, Ruth M, Lundell L. Mechanism of action of antireflux procedures. Br J Surg. 1999 Mar;86(3):405-10. — View Citation

Smout AJ. The patient with GORD and chronically recurrent problems. Best Pract Res Clin Gastroenterol. 2007;21(3):365-78. Review. — View Citation

Stylopoulos N, Rattner DW. The history of hiatal hernia surgery: from Bowditch to laparoscopy. Ann Surg. 2005 Jan;241(1):185-93. Review. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour pH impedance study: change in Johnson DeMeester scores; GERD-HRQOL scores		1, 3, 6, 12 month	No
Secondary	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.		1 day; 1 week; 1, 3, 6, 12 month	No