Gastroesophageal Reflux Disease (GERD)TIF-LPRNCT05579587
Transoral Incisionless Fundoplication (TIF) for Laryngopharyngeal Reflux (LPR) Patients
An observational study of Gastroesophageal Reflux Disease (GERD) and Laryngopharyngeal Reflux (LPR), run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD), Laryngopharyngeal Reflux (LPR), Reflux Disease, Gastro-Esophageal
- What is being tested?
- Transoral Incisionless Fundoplication
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2024to 28 Feb 2025
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with diagnosed Laryngopharyngeal reflux (LPR) who are scheduled for endoscopic transoral incisionless fundoplication procedure (TIF).
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the detailed description
To date, more than one-third of the motility patients that the investigators see in practice at Brigham and Women's Hospital have LPR. There is currently limited literature available addressing LPR as a primary indication for the TIF procedure moreover there is no single therapy that has proved its efficacy over the years against LPR. The investigators propose a pilot study to investigate the efficacy of TIF with the EsophyX device (EndoGastric Solutions, Inc., Redmond WA, USA) in patients with LPR. The study design would include up to 25 patients to receive the TIF procedure and will take 12 months to complete it. The investigators will compare objective and subjective outcomes at baseline and 3 months post TIF procedure to assess its efficacy against LPR. The investigators will submit the proposal to EndoGastric solutions, anticipating that they will cover part of the funding required to conduct our Pilot Study.
In conclusion, LPR lacks an effective therapy despite posing a significant healthcare burden. Medical therapy with PPI has a variable response, and more invasive Laparoscopic fundoplication is associated with a high risk of unwanted long-term side effects. TIF can potentially bridge this gap between medical and more invasive approaches for the patient population suffering from this condition. It has the potential to prove to be a less invasive and safe treatment indication for patients with chronic or refractory LPR who have either failed medical therapy or do not want to be on long-term medical treatment.
- Conditions
- Gastroesophageal Reflux Disease (GERD), Laryngopharyngeal Reflux (LPR), Reflux Disease, Gastro-Esophageal, Motility Disorder
- Being tested
- Transoral Incisionless Fundoplication
- Keywords
- Transoral Incisionless Fundoplication (TIF), Fundoplication, Nissen Fundoplication, Proton Pump Inhibitor, Esophageal Manometry, Laryngoscopy, HEMII-pH, Reflux Symptom Index (RSI), GERD-HRQL
- Medical subject headings
- Gastroesophageal Reflux, Laryngopharyngeal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral Incisionless FundoplicationDevice
Also called TIF
Transoral incisionless fundoplication (TIF) is a minimally invasive, endoscopic fundoplication technique. Transoral Incisionless Fundoplication (TIF) is an FDA approved endoluminal fundoplication technique which utilizes EsophyX device to restore the valve at the gastroesophageal junction. The EsophyX device (EndoGastric Solutions, Redmond, Wash, USA) is an FDA approved procedure for chronic of refractory GERD.
| Study group | Role | What they receive |
|---|---|---|
| LPR Patients | Adults with a confirmed diagnosis of LPR with HEMII-pH (≥2 LPR events in 24 hr period), Esophageal manometry and Laryngoscopy undergoing endoscopic transoral incisionless fundoplication (TIF). Receives: Device: Transoral Incisionless Fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
LPR Symptoms
Number of participants reporting LPR symptom elimination or clinically significant improvement evaluated by RSI (Reflux Symptom Index) and GERD-HRQL Questionnaire.
Measured: Baseline and 3 months post-procedure
LPR Events
Number of participants with reduced LPR events as evaluated by HEMII-pH
Measured: Baseline and 3 months post-procedure
Secondary outcomes (5)
GERD Symptoms
Elimination of Daily bothersome GERD symptoms evaluated by GERD-HRQL Questionnaire
Measured: Baseline and 3 months post-procedure
Patient Satisfaction
Patients Satisfaction evaluated by GERD-HRQL Questionnaire
Measured: Baseline and 3 months post-procedure
Lower Esophageal Sphincter Tone
Change in Lower esophageal sphincter tone evaluated by Esophageal manometry
Measured: Baseline and 3 months post-procedure
Laryngopharyngeal anatomy
Change in Laryngopharyngeal anatomy evaluated by Laryngoscopy
Measured: Baseline and 3 months post-procedure
PPI Discontinuation
Discontinuation of PPI's
Measured: Baseline and 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start30 Mar 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Why it stopped: Sponsor decided not to fund the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- EndoGastric Solutions
- Responsible party
- Principal investigator, Christopher C. Thompson, MD, MSc, Brigham and Women's Hospital
- Investigators
- Christopher C. Thompson, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579587
- Sponsor's protocol ID
- 2022P000144
- Acronym
- TIF-LPR
- Status last verified
- Aug 2024
- First submitted
- 11 Oct 2022
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The plan to share data will be on a case by case basis. The other researchers may contact the PI and discuss study plans. An agreement through Mass General Brigham will need to be executed prior to sharing the de-identified data.
Publications
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.
PubMed 23853213Koufman 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.
PubMed 1895864Francis 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.
PubMed 23545710Spantideas 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.
PubMed 31160182Fraser 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.
PubMed 22890365Lazarus 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.
PubMed 26752337Ciovica 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.
PubMed 16843863Galmiche 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.
PubMed 21586712McCarty 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.
PubMed 29625507Testoni 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.
PubMed 33553587Barnes 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.
PubMed 21307014Wilson 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.
PubMed 24487156Trad 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.
PubMed 29405886Borges 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.
PubMed 30082108Carroll 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.
PubMed 27217426
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transoral Incisionless Fundoplication (TIF) for Laryngopharyngeal Reflux (LPR) Patients
- ClinicalTrials.gov ID
- NCT05579587
- Acronym / sponsor ID
- TIF-LPR / 2022P000144
- Conditions
- Gastroesophageal Reflux Disease (GERD), Laryngopharyngeal Reflux (LPR), Reflux Disease, Gastro-Esophageal, Motility Disorder
- Keywords
- Transoral Incisionless Fundoplication (TIF), Fundoplication, Nissen Fundoplication, Proton Pump Inhibitor, Esophageal Manometry, Laryngoscopy, HEMII-pH, Reflux Symptom Index (RSI)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decided not to fund the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- EndoGastric Solutions
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To date, more than one-third of the motility patients that the investigators see in practice at Brigham and Women's Hospital have LPR. There is currently limited literature available addressing LPR as a primary indication for the TIF procedure moreover there is no single therapy that has proved its efficacy over the years against LPR. The investigators propose a pilot study to investigate the efficacy of TIF with the EsophyX device (EndoGastric Solutions, Inc., Redmond WA, USA) in patients with LPR. The study design would include up to 25 patients to receive the TIF procedure and will take 12 months to complete it. The investigators will compare objective and subjective outcomes at baseline and 3 months post TIF procedure to assess its efficacy against LPR. The investigators will submit the proposal to EndoGastric solutions, anticipating that they will cover part of the funding required to conduct our Pilot Study.
In conclusion, LPR lacks an effective therapy despite posing a significant healthcare burden. Medical therapy with PPI has a variable response, and more invasive Laparoscopic fundoplication is associated with a high risk of unwanted long-term side effects. TIF can potentially bridge this gap between medical and more invasive approaches for the patient population suffering from this condition. It has the potential to prove to be a less invasive and safe treatment indication for patients with chronic or refractory LPR who have either failed medical therapy or do not want to be on long-term medical treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LPR Patients | – | Device: Transoral Incisionless FundoplicationAdults with a confirmed diagnosis of LPR with HEMII-pH (≥2 LPR events in 24 hr period), Esophageal manometry and Laryngoscopy undergoing endoscopic transoral incisionless fundoplication (TIF). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with diagnosed Laryngopharyngeal reflux (LPR) who are scheduled for endoscopic transoral incisionless fundoplication procedure (TIF).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Transoral Incisionless FundoplicationAlso: TIFTransoral incisionless fundoplication (TIF) is a minimally invasive, endoscopic fundoplication technique. Transoral Incisionless Fundoplication (TIF) is an FDA approved endoluminal fundoplication technique which utilizes EsophyX device to restore the valve at the gastroesophageal junction. The EsophyX device (EndoGastric Solutions, Redmond, Wash, USA) is an FDA approved procedure for chronic of refractory GERD. | Device | LPR Patients |
Primary outcome
LPR Symptoms
Time frame: Baseline and 3 months post-procedure
Number of participants reporting LPR symptom elimination or clinically significant improvement evaluated by RSI (Reflux Symptom Index) and GERD-HRQL Questionnaire.
LPR Events
Time frame: Baseline and 3 months post-procedure
Number of participants with reduced LPR events as evaluated by HEMII-pH
5 secondary outcomes
GERD Symptoms
Time frame: Baseline and 3 months post-procedure
Patient Satisfaction
Time frame: Baseline and 3 months post-procedure
Lower Esophageal Sphincter Tone
Time frame: Baseline and 3 months post-procedure
Laryngopharyngeal anatomy
Time frame: Baseline and 3 months post-procedure
PPI Discontinuation
Time frame: Baseline and 3 months post-procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 23853213El-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.
- Background: PubMed 1895864Koufman 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.
- Background: PubMed 23545710Francis 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.
- Background: PubMed 31160182Spantideas 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.
- Background: PubMed 22890365Fraser 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.
- Background: PubMed 26752337Lazarus 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.
- Background: PubMed 16843863Ciovica 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.
- Background: PubMed 21586712Galmiche 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.
- Background: PubMed 29625507McCarty 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.
- Background: PubMed 33553587Testoni 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.
- Background: PubMed 21307014Barnes 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.
- Background: PubMed 24487156Wilson 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.
- Safety information for the TIF procedureLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The plan to share data will be on a case by case basis. The other researchers may contact the PI and discuss study plans. An agreement through Mass General Brigham will need to be executed prior to sharing the de-identified data.
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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.
Christopher C. Thompson, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease (GERD) and Laryngopharyngeal Reflux (LPR), run by Brigham and Women's Hospital 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 17 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 5 Aug 2024. 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?
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?
LPR Symptoms (time frame: Baseline and 3 months post-procedure). The study lists 2 primary outcomes in all. 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 NCT05579587, which also lists 17 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 5 Aug 2024.