臨床研究等提出・公開システム

A First-in-Human, Investigator-Initiated Trial to Evaluate the Safety and Efficacy of Superior Mesenteric Artery Denervation (SMADN) in Refractory Chronic Constipation

ALV01

Tanaka Toshihiro

Nara Medical University Hospital

840 Shijocho, Kashihara City, Nara Prefecture, 634-8522, Japan

totanaka@naramed-u.ac.jp

Nishiofuku Hideyuki

Nara Medical University Hospital

840 Shijocho, Kashihara City, Nara Prefecture, 634-8522, Japan

+81-744-22-3051

hmn@naramed-u.ac.jp

Recruiting

May. 13, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1)Subjects aged 18 years or older at the time of obtaining informed consent.
(2)Subjects who have provided written informed consent.
(3)Subjects who meet the diagnostic criteria for chronic constipation according to the Rome IV criteria.
(4) Subjects who have fewer than three spontaneous bowel movements (SBMs) per week despite adequate conventional treatment.
(5) Subjects diagnosed with slow-transit constipation by a constipation specialist based on a comprehensive evaluation of medical interview, digital rectal examination, defecography, and the Sitzmarks(R) 3-day method.

(1)Subjects who meet the Rome IV criteria for irritable bowel syndrome with diarrhea (IBS-D).
(2)Subjects with a history of or current inflammatory bowel disease.
(3)Subjects with active infectious enteritis at the time of enrollment.
(4)Subjects with a history of or current stoma.
(5)Subjects with a history of or current functional defecation disorders among functional constipation.
(6)Subjects with a history of or current organic defecatory disorder among non-obstructive organic constipation
(7) Subjects with drug-induced constipation in whom the causative drug has been identified and for whom improvement is expected through discontinuation or dose reduction of the causative drug, or administration of an antagonist.
(8)Subjects with a history of or current stenotic organic constipation.
(9)Subjects with a history of or current Hirschsprung's disease or allied disorders.
(10)Subjects with hypersensitivity to barium sulfate or any component of Sitzmarks(R).
(11)Subjects with allergy to rice bran used in defecography.
(12)Subjects with anatomical variations or morphological abnormalities of the superior mesenteric artery (SMA) (e.g., celiacomesenteric type, calcification involving >=50% of the vessel circumference, stenosis, dissection, or aneurysmal dilation (<=70% or >=150% of the normal vessel diameter).
(13)Subjects who are unable to discontinue anticoagulant therapy before and after superior mesenteric artery denervation (SMADN) treatment.
(14)Subjects with a history of allergy to iodinated contrast agents.
(15)Subjects with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2.
(16)Subjects diagnosed with an active infection.
(17)Subjects diagnosed with an uncontrolled bleeding tendency.
(18)Subjects who are pregnant, planning to become pregnant during the study period, or unwilling to use contraception during the study period.
(19)Subjects deemed inappropriate for participationby the principal investigator or sub-investigator.

Both

Refractory Chronic Constipation

Transcatheter ablation of sympathetic nerves surrounding the superior mesenteric artery (SMA) using the investigational device

D003248

(1)Adverse Events(AEs) and Adverse Drug Reactions(ADRs)
(2)Serious Adverse Events (SAEs)
(3)Device Deficiencies

(1) Change in the Frequency of Spontaneous Bowel Movements (SBMs)
(2)Change in the Frequency of Complete Spontaneous Bowel Movements (CSBMs)
(3) Change in Quality of Life as Assessed by the Japanese Version of the Patient Assessment of Constipation Quality of Life Questionnaire (JPAC-QOL)
Change in Bristol Stool Form Scale Score
(5)Change in the Modified Cleveland Clinic Constipation Score (mCSS)
(6)Change in the Type and Dosage of Constipation Medications, Excluding Rescue Medications
(7) Change in the Type, Dosage, and Frequency of Rescue Medications
(8)Improvement in Colonic Transit Time as Assessed by the 3-Day Sitzmarks(R) Method

+81-744-22-3051

April. 16, 2026

No

none