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Tests treatment safety and results for Hemorrhoids
Official title SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids
ClinicalTrials.gov ID: NCT05782010
What this study is testing
- What it's testing
- The SCI-Pex study is a multicenter, prospective, non-controlled investigation on PexyEazy®, a new device for treatment of hemorrhoids based on the mucopexy method. Mucopexy is a well established method where sutures are applied above the hemorrhoids.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 84
You may be able to join if
- Adult
- Hemorrhoidal disease grade II and III
- American Society of Anesthesiologists (ASA) classification I-III.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- Adult
- Hemorrhoidal disease grade II and III
- American Society of Anesthesiologists (ASA) classification I-III.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Frölunda, Sweden
- Norrtälje, Sweden
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 84 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frölunda, Sweden; Norrtälje, Sweden; Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.