Phase
Condition
Colic
Ulcerative Colitis (Pediatric)
Dysmenorrhea (Painful Periods)
Treatment
Main Group
Clinical Study ID
Ages 18-130 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have been clinically diagnosed with CAP (from inguinal crease to T12 ribs),including diagnoses such as abdominal wall pain, chronic pancreatitis,gastroparesis, gastric dysmotility, irritable bowel syndrome, post-surgical orpost-traumatic abdominal pain that is of visceral origin.
Have been refractory to conservative therapy for a minimum of 3-months, includingassessment of at least 2 different classes of medications and/or an anaestheticblock as clinically appropriate.
Minimum baseline pain score of 5 on a VAS scale (0-10) for their visceral pain.
Be 18 years of age or older at the time of enrolment.
Be an appropriate candidate for the surgical procedures required in this study basedon the clinical judgment of the implanting physician.
Be willing and capable of giving informed consent.
Be willing and able to comply with study-related requirements, procedures, andvisits.
Exclusion
Exclusion Criteria:
Female participants of childbearing potential who are pregnant/nursing or plan tobecome pregnant during the trial.
Escalating or changing pain condition within the past month as evidenced byinvestigator examination.
Sphlanchnectomy or radiofrequency treatment within the past 6-months.
Currently has an active or had an active implantable device including pacemakers,SCS or intrathecal drug delivery system.
In the investigators opinion has an active infection.
Participated in another clinical investigation within 30-days.
Medical co-morbidities that preclude surgical intervention.
Participant is incapable of understanding or responding to the study questionnaires.
Participant is incapable of understanding or operating the patient programmerhandset.
Participant is morbidly obese (BMI ≥ 40 kg/m2).
Participant has had a spinal surgical procedure or has spinal pathology that wouldsignificantly impede lead implantation at the level planned for implantation.
Participant has another persistent painful condition other than persistentrefractory visceral pain secondary to chronic abdominal pain.
History of alcohol abuse in the last year or IV drug abuse in the last 3-years.
No increases of more than 40% from baseline amylase.
Have a condition currently requiring or likely to require the use of diathermy.
Study Design
Study Description
Connect with a study center
Leeds Teaching Hospitals NHS Trust
Leeds,
United KingdomActive - Recruiting
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