Ignite Creation Date:
2024-05-06 @ 6:11 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05579587
Status:
WITHDRAWN
Last Update Posted:
2023-12-14
First Post:
2022-10-11
Brief Title:
Transoral Incisionless Fundoplication TIF for Laryngopharyngeal Reflux LPR Patients
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Transoral Incisionless Fundoplication TIF for Laryngopharyngeal Reflux LPR Patients
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decided not to fund the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIF-LPR
Brief 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 bodys 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 larynxhypopharynx 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 Womens 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None