Botulinum toxin injection in the upper esophageal sphincter for retrograde-cricopharyngeus dysfunction: a double blind, placebo-controlled trial. - 52082

Algemeen Ziekenhuis Delta0 个研究点目标入组 30 人开始时间: 2024年4月16日最近更新: 2024年7月22日

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•Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures, Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner., Between 18 and 65 years old, Inability to belch, which is bothersome enough to consider treatment, with or without any of the concomitant symptoms (bloathing, flatulence, gurgling noises, etc), Typical findings on high resolution impedance manometry with belch provocation test

•Participant has a history of surgery in the upper GI tract, that might interfere with the belch reflex (such as anti-reflux surgery), Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol, Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial, to be decided at the discretion of the investigator., If applicable: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive, Participation in another interventional Trial with an investigational medicinal product (IMP) or device, >65 years old; < 18 years of age

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