SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids (SCI-Pex)
Hemorrhoids, Hemorrhoids, Internal, Suture; Complications, Infection or Inflammation
About this trial
This is an interventional treatment trial for Hemorrhoids focused on measuring PexyEazy
Eligibility Criteria
Inclusion Criteria: Adult Hemorrhoidal disease grade II and III American Society of Anesthesiologists (ASA) classification I-III. Exclusion Criteria: Previous surgical treatment for hemorrhoids by all methods except rubber band ligation or sclerosing injection therapy within the last 3 years. Previous surgical treatment with rubber band ligation or injection therapy within the last 2 months. More than three surgical treatments with rubber band ligation or sclerosing injection therapy within the last 3 years. Under medication with immunosuppressive drugs and/or anticoagulant drugs (not including 75mg acetylsalicylic acid) and not able to interrupt the anticoagulant drug medication or replace it with low molecular weight heparin for 5 days. Have ulcerative colitis, Crohn's disease or other intestinal inflammatory disease or presence of inflamed or thickened mucosa of the rectum. Presence of anal fissure, anal stenosis, stricture, fistulas or ulcers in the rectal area. The rectum has not been prepared prior to the investigation with rectal enema and is contaminated with feces that cannot easily be removed. Have schizophrenia, untreated depression or other mental illness or conditions that may affect judgment, sensation of pain or inability to complete the follow-up. Under medication of morphine or other strong painkillers, not including paracetamol. Fecal incontinence (not including soiling due to hemorrhoidal disease), or conditions with impaired sensation in the rectal area or impaired function of the anal sphincter. Previous rectal radiation. Rectal cancer or previous surgery due to rectal cancer. Pregnancy Hypercoagulability disorders or diseases that result in increased risk of bleeding. Impaired immune system or condition that increases the risk of infection.
Sites / Locations
- Frölunda SpecialistsjukhusRecruiting
- Norrtälje Sjukhus
Arms of the Study
Arm 1
Experimental
PexyEazy procedure
PexyEazy procedure on patients with hemorrhoidal disease grade II and III. The study is descriptive and non-comparable to evaluate the safety and performance of PexyEazy.