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

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ClinicalTrials.gov Identifier: NCT02698644
Recruitment Status : Unknown
Verified February 2016 by Mohamed I Amer, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Mohamed I Amer, Ain Shams University

Brief 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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Occlusion Drug: Isoamyl-2-cyanoacrylate Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Hysteroscopic Tubal Occlusion With the Use of Iso Amyl-2-cyanoacrylate
Study Start Date : January 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tubal Ligation

Arm Intervention/treatment
Experimental: isoamyl2cyanoacrylate
Isoamyl-2-cyanoacrylate will be injected inside fallopian tube hysteroscopically through ureteric catheter
Drug: Isoamyl-2-cyanoacrylate
Isoamyl-2-cyanoacrylate will be injected inside fallopian tube hysteroscopically through ureteric catheter
Other Name: AMCRYLATE®




Primary Outcome Measures :
  1. fallopian tube obstruction [ Time Frame: from one day to four weeks ]
    assessed by failure of passage of methylene blue through fallopian tubes after injecting it transcervical in the hysterectomy spacements.


Secondary Outcome Measures :
  1. degree and extend of inflammation in the fallopian tubes [ Time Frame: from one day to four weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698644


Contacts
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Contact: Mohamed I Amer, MD 00201001519370 mohamed_amer810@yahoo.com

Locations
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Egypt
AIn Shams University Maternity Hospital Recruiting
Cairo, Egypt, 11357
Contact: Mohamed Amer, MD    00201001519370    mohamed_amer810@yahoo.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Mohamed I Amer, MD Ain Shams University maternity hospital
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Responsible Party: Mohamed I Amer, Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT02698644    
Other Study ID Numbers: ASU
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided