Gastroesophageal Reflux Disease (GERD) Clinical Trial
— TIF-LPROfficial title:
Transoral Incisionless Fundoplication (TIF) for Laryngopharyngeal Reflux (LPR) Patients
In this research study the investigators want to learn more about the effectiveness of an endoscopic procedure (an endoscope is a lighted tube that is placed down the participants esophagus, through the participants mouth) which uses a device that allows the doctor to repair or recreate the body's natural barrier to reflux. It uses preloaded forceps (tweezers) and fasteners and requires no incision to tighten the connection between the participants esophagus and stomach. This procedure is performed to aid in the treatment of symptoms of Gastroesophageal Reflux disease (GERD) in patients with diagnosed Laryngopharyngeal reflux (LPR). LPR is a condition resulting from backflow of stomach contents into the laryngopharynx (connection point in the participants throat through which food, water, and air pass) resulting in symptoms that can be referred to larynx/hypopharynx. The device the investigators will use to perform the transoral incisionless fundoplication procedure (TIF) is called the EsophyX device. The participants have been asked to participate because they have been diagnosed with LPR and have either failed medical therapy (taking prescription proton pump inhibitors (PPI) to reduce stomach acid production or do not want to be on long-term medical treatment.
Status | Not yet recruiting |
Enrollment | 25 |
Est. completion date | February 28, 2025 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Any adult with a confirmed diagnosis of LPR with HEMII-pH (=2 LPR events in 24 hr period), Esophageal manometry and Laryngoscopy. - Having daily bothersome symptoms of LPR. - Willing and able to cognitively sign a consent form for Surgical treatment of LPR with the TIF. - Willing and available for follow up visit and repeat testing (HEMII-pH, Esophageal manometry and laryngoscopy) at 3 months post procedure. Exclusion Criteria: - Unable or unwilling to provide informed consent - Unable or unwilling to comply with study procedures - Body Mass Index >35. - Hiatal hernia>2cm in axial height and >2cm in greatest transverse dimension. - Esophagitis grade C and D - Barrett's esophagus>2cm - Esophageal ulcer - Fixed esophageal stricture or narrowing - Portal hypertension and/or varices - Active gastro-duodenal ulcer disease; Gastric outlet obstruction or stenosis - Gastroparesis - Coagulation disorders - History of any of the following: resective gastric or esophageal surgery, anti-reflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis - Pregnancy or plans of pregnancy in the next 12 months - Enrollment in another device or drug study that may confound the results. - Acute or chronic illness or history of illness which in the opinion of the investigator could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data, such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes (HbA1c >12%), etc. - Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the investigator. |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | EndoGastric Solutions |
United States,
Barnes WE, Hoddinott KM, Mundy S, Williams M. Transoral incisionless fundoplication offers high patient satisfaction and relief of therapy-resistant typical and atypical symptoms of GERD in community practice. Surg Innov. 2011 Jun;18(2):119-29. doi: 10.1177/1553350610392067. Epub 2011 Feb 8. — View Citation
Borges LF, Chan WW, Carroll TL. Dual pH Probes Without Proximal Esophageal and Pharyngeal Impedance May Be Deficient in Diagnosing LPR. J Voice. 2019 Sep;33(5):697-703. doi: 10.1016/j.jvoice.2018.03.008. Epub 2018 Aug 3. — View Citation
Carroll TL, Nahikian K, Asban A, Wiener D. Nissen Fundoplication for Laryngopharyngeal Reflux After Patient Selection Using Dual pH, Full Column Impedance Testing: A Pilot Study. Ann Otol Rhinol Laryngol. 2016 Sep;125(9):722-8. doi: 10.1177/0003489416649974. Epub 2016 May 23. — View Citation
Ciovica R, Gadenstatter M, Klingler A, Lechner W, Riedl O, Schwab GP. Quality of life in GERD patients: medical treatment versus antireflux surgery. J Gastrointest Surg. 2006 Jul-Aug;10(7):934-9. doi: 10.1016/j.gassur.2006.04.001. — View Citation
El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014 Jun;63(6):871-80. doi: 10.1136/gutjnl-2012-304269. Epub 2013 Jul 13. — View Citation
Francis DO, Rymer JA, Slaughter JC, Choksi Y, Jiramongkolchai P, Ogbeide E, Tran C, Goutte M, Garrett CG, Hagaman D, Vaezi MF. High economic burden of caring for patients with suspected extraesophageal reflux. Am J Gastroenterol. 2013 Jun;108(6):905-11. doi: 10.1038/ajg.2013.69. Epub 2013 Apr 2. — View Citation
Fraser LA, Leslie WD, Targownik LE, Papaioannou A, Adachi JD; CaMos Research Group. The effect of proton pump inhibitors on fracture risk: report from the Canadian Multicenter Osteoporosis Study. Osteoporos Int. 2013 Apr;24(4):1161-8. doi: 10.1007/s00198-012-2112-9. Epub 2012 Aug 14. — View Citation
Galmiche JP, Hatlebakk J, Attwood S, Ell C, Fiocca R, Eklund S, Langstrom G, Lind T, Lundell L; LOTUS Trial Collaborators. Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial. JAMA. 2011 May 18;305(19):1969-77. doi: 10.1001/jama.2011.626. — View Citation
Hoppo T, Komatsu Y, Jobe BA. Antireflux surgery in patients with chronic cough and abnormal proximal exposure as measured by hypopharyngeal multichannel intraluminal impedance. JAMA Surg. 2013 Jul;148(7):608-15. doi: 10.1001/jamasurg.2013.1376. — View Citation
Koufman JA. The otolaryngologic manifestations of gastroesophageal reflux disease (GERD): a clinical investigation of 225 patients using ambulatory 24-hour pH monitoring and an experimental investigation of the role of acid and pepsin in the development of laryngeal injury. Laryngoscope. 1991 Apr;101(4 Pt 2 Suppl 53):1-78. doi: 10.1002/lary.1991.101.s53.1. — View Citation
Lazarus B, Chen Y, Wilson FP, Sang Y, Chang AR, Coresh J, Grams ME. Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease. JAMA Intern Med. 2016 Feb;176(2):238-46. doi: 10.1001/jamainternmed.2015.7193. — View Citation
McCarty TR, Itidiare M, Njei B, Rustagi T. Efficacy of transoral incisionless fundoplication for refractory gastroesophageal reflux disease: a systematic review and meta-analysis. Endoscopy. 2018 Jul;50(7):708-725. doi: 10.1055/a-0576-6589. Epub 2018 Apr 6. — View Citation
Spantideas N, Drosou E, Bougea A, AlAbdulwahed R. Proton Pump Inhibitors for the Treatment of Laryngopharyngeal Reflux. A Systematic Review. J Voice. 2020 Nov;34(6):918-929. doi: 10.1016/j.jvoice.2019.05.005. Epub 2019 May 31. — View Citation
Testoni S, Hassan C, Mazzoleni G, Antonelli G, Fanti L, Passaretti S, Correale L, Cavestro GM, Testoni PA. Long-term outcomes of transoral incisionless fundoplication for gastro-esophageal reflux disease: systematic-review and meta-analysis. Endosc Int Open. 2021 Feb;9(2):E239-E246. doi: 10.1055/a-1322-2209. Epub 2021 Feb 3. — View Citation
Trad KS, Barnes WE, Prevou ER, Simoni G, Steffen JA, Shughoury AB, Raza M, Heise JA, Fox MA, Mavrelis PG. The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective. Surg Innov. 2018 Apr;25(2):149-157. doi: 10.1177/1553350618755214. Epub 2018 Feb 6. — View Citation
Wilson EB, Barnes WE, Mavrelis PG, Carter BJ, Bell RC, Sewell RW, Ihde GM, Dargis D, Hoddinott KM, Shughoury AB, Gill BD, Fox MA, Turgeon DG, Freeman KD, Gunsberger T, Hausmann MG, Leblanc KA, Deljkich E, Trad KS. The effects of transoral incisionless fundoplication on chronic GERD patients: 12-month prospective multicenter experience. Surg Laparosc Endosc Percutan Tech. 2014 Feb;24(1):36-46. doi: 10.1097/SLE.0b013e3182a2b05c. — View Citation
Zerbib F, Roman S, Bruley Des Varannes S, Gourcerol G, Coffin B, Ropert A, Lepicard P, Mion F; Groupe Francais De Neuro-Gastroenterologie. Normal values of pharyngeal and esophageal 24-hour pH impedance in individuals on and off therapy and interobserver reproducibility. Clin Gastroenterol Hepatol. 2013 Apr;11(4):366-72. doi: 10.1016/j.cgh.2012.10.041. Epub 2012 Nov 8. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | LPR Symptoms | Number of participants reporting LPR symptom elimination or clinically significant improvement evaluated by RSI (Reflux Symptom Index) and GERD-HRQL Questionnaire. | Baseline and 3 months post-procedure | |
Primary | LPR Events | Number of participants with reduced LPR events as evaluated by HEMII-pH | Baseline and 3 months post-procedure | |
Secondary | GERD Symptoms | Elimination of Daily bothersome GERD symptoms evaluated by GERD-HRQL Questionnaire | Baseline and 3 months post-procedure | |
Secondary | Patient Satisfaction | Patients Satisfaction evaluated by GERD-HRQL Questionnaire | Baseline and 3 months post-procedure | |
Secondary | Lower Esophageal Sphincter Tone | Change in Lower esophageal sphincter tone evaluated by Esophageal manometry | Baseline and 3 months post-procedure | |
Secondary | Laryngopharyngeal anatomy | Change in Laryngopharyngeal anatomy evaluated by Laryngoscopy | Baseline and 3 months post-procedure | |
Secondary | PPI Discontinuation | Discontinuation of PPI's | Baseline and 3 months post-procedure |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03561883 -
Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
|
Phase 3 | |
Completed |
NCT01406210 -
RESULT (REflux Surgery in Lung Transplantation) Preliminary Study Protocol
|
N/A | |
Completed |
NCT02555852 -
Proton Pump Inhibitors and Risk of Community-acquired Pneumonia
|
N/A | |
Terminated |
NCT01327963 -
Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study
|
N/A | |
Completed |
NCT01570842 -
Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
|
N/A | |
Completed |
NCT02141711 -
TAK-438 - Safety, Blood Levels & Effects of Repeated Doses
|
Phase 1 | |
Terminated |
NCT00587275 -
Safety and Efficacy of AST-120 in Patients With GERD Who Continue to be Symptomatic on a Standard Dose of PPI
|
Phase 2 | |
Completed |
NCT00228527 -
Esomeprazole for Treatment of GERD in Pediatric Patients
|
Phase 4 | |
Completed |
NCT00261300 -
Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)
|
Phase 3 | |
Recruiting |
NCT04506593 -
Indiana University Gastrointestinal Motility Diagnosis Registry
|
||
Completed |
NCT00795093 -
Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US
|
N/A | |
Completed |
NCT00394472 -
Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
|
Phase 2 | |
Completed |
NCT00574925 -
Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients
|
Phase 4 | |
Terminated |
NCT02749071 -
An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux
|
N/A | |
Recruiting |
NCT01129713 -
Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.
|
Phase 1/Phase 2 | |
Completed |
NCT00734747 -
Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
|
Phase 3 | |
Completed |
NCT00312806 -
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
|
Phase 3 | |
Recruiting |
NCT02366169 -
Medigus Ultrasonic Surgical Endostapler (MUSE) Registry
|
N/A | |
Completed |
NCT01374074 -
Racial Disparity in Barrett's Esophagus
|
N/A | |
Terminated |
NCT00857597 -
Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
|
Phase 3 |