Hysteroscopic Tubal Occlusion With the Use of Iso Amyl-2-cyanoacrylate

Fallopian Tube Occlusion Clinical Trial

Official title:

Hysteroscopic Tubal Occlusion With the Use of Iso Amyl-2-cyanoacrylate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02698644
• Other study ID #: ASU
• Status: Recruiting
• Phase: Phase 1
• First received: February 19, 2016
• Last updated: February 29, 2016
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: February 2016
• Source: Ain Shams University
• Contact: Mohamed I Amer, MD
• Phone: 00201001519370
• Email: mohamed_amer810[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

Is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of women, which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF and in tubal sterilization.

Description:

The study will be conducted according to the guidelines on human experimentation of the 1975 Declaration of Helsinki. For all patients after taking signed informed consent , transcervical hysteroscopic cannulation of the proximal one centimeter of both fallopian tubes, will be done using a 5 Fr, 42cm long, polyethylene ureteric catheter, where 0.5 ml of Iso Amyl-2-cyanoacrylate (AMCRYLATE®) will be injected in each side.

All the surgical procedures will be performed without anesthesia, only premedication with an NSAID (e.g. NaproxenR) is given orally one hour before the procedure.

Each patient will be under close observation for the first 24 hours postprocedure for any signs of inflammation as abdominal pain, tenderness or fever and for the vital data.

Total abdominal hysterectomy and bilateral salpingoophorectomy will be done, second day, a week, two weeks and three weeks and four weeks after injection,. Hysterectomy samples will be sent to histopathologist to assess the degree of tubal occlusion and the extent and the severity of inflammation in the tubal wall.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

Inclusion Criteria:

• patients planned for abdominal hysterectomy with well seen tubal ostia through hysteroscope

Exclusion Criteria:

• Any patient with Upper or lower genital tract infection as evidenced by fever, lower abdominal pain or tenderness and abnormal vaginal discharge will be excluded from the study

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fallopian Tube Occlusion

Intervention

Drug:
• Isoamyl-2-cyanoacrylate
Isoamyl-2-cyanoacrylate will be injected inside fallopian tube hysteroscopically through ureteric catheter

Locations

Country	Name	City	State
Egypt	AIn Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fallopian tube obstruction	assessed by failure of passage of methylene blue through fallopian tubes after injecting it transcervical in the hysterectomy spacements.	from one day to four weeks	Yes
Secondary	degree and extend of inflammation in the fallopian tubes	assessments of this outcome will be done by histopathological examination for severity of inflammatory cellular changes and extend of these inflammatory changes through different layers of the wall of the fallopian tubes	from one day to four weeks	Yes